510(k) Report

510(k) · Decided

Decided

Range Spinal System

K121630510(k) TraditionalDecided Sep 11, 201299-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Cleared on Sep 11, 2012 as substantially equivalent to K994121 (Synthes (Usa), 2000) and 13 other predicates after a 99-day review. Its family tree reaches back 12 generations to 2004. 127 later devices descend from it.

Decided
Sep 11, 2012
Review
99 days
Class
Class II
Product code
OSH
Recalls
None
Predicates
15

Its longest line of descent runs back 12 generations to K040583 (2004). 152 ancestors in all, the oldest K781443 (1978). 127 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors2011: 5 other ancestors2010: 4 other ancestors2008: 7 other ancestors2000: 14 other ancestors2009: 3 other ancestors2007: 3 other ancestors2005: 13 other ancestors2004: 21 other ancestors2003: 11 other ancestors2002: 10 other ancestors2001: 14 other ancestors1999: 3 other ancestors1998: 8 other ancestors1997: 2 other ancestors1996: 6 other ancestors1978: 1 other ancestor2006: 8 other ancestors1995: 3 other ancestors1994: 1 other ancestor1984: 1 other ancestor2013: 7 descendants cleared2017: 7 descendants cleared2014: 6 descendants cleared2016: 6 descendants cleared2015: 8 descendants cleared2024: 14 descendants cleared2018: 9 descendants cleared2026: 12 descendants cleared2025: 9 descendants cleared2021: 8 descendants cleared2022: 14 descendants cleared2023: 16 descendants cleared2019: 6 descendants cleared2020: 5 descendants cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 41 other ancestors3 generations back: 51 other ancestors4 generations back: 18 other ancestors5 generations back: 12 other ancestors6 generations back: 7 other ancestors 1 generation forward: 12 descendants2 generations forward: 21 descendants3 generations forward: 15 descendants4 generations forward: 19 descendants5 generations forward: 27 descendants6 generations forward: 19 descendants7 generations forward: 11 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50+5
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 8 generations between
  3. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  4. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  5. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  6. This deviceK121630 Range Spinal SystemK2m, Inc. · 2012
  7. Descendant · cites it directly · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
  8. Descendant · 2 generations on · 78 of its ownK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
  9. Descendant · 2 generations on · 73 of its ownK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
  10. Descendant · 3 generations on · 61 of its ownK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
  11. Descendant · cites it directly · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
Show all 12 generations
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. This deviceK121630 Range Spinal SystemK2m, Inc. · 2012

Showing 5 of 127 descendants. See all descendants

Descendants cleared per year

2013: 72014: 62015: 82016: 62017: 72018: 92019: 62020: 52021: 82022: 142023: 162024: 142025: 92026: 12
2013high 16 (2023) · low 5 (2020)2026

Most influential descendants

Showing 5 of 127 · See all
  • K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · cites it directly81descendants
  • K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · 2 generations on78descendants
  • K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · 2 generations on73descendants
  • K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc. · 2017 · 3 generations on61descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · cites it directly41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−10K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−9K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−7K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
0 (this device)K121630Range Spinal SystemK2m, Inc.2012—
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.20131
+2K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20151
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.20161
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS…Orthofix, Inc.20171
+1K132757Everest Spinal SystemK2m, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199530
199660
199720
199880
199930
2000140
2001140
2002100
2003110
2004210
2005130
200680
200730
200870
200930
201040
201150
201220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201370
201460
201580
201660
201770
201890
201960
202050
202180
2022140
2023160
2024140
202590
2026120
FIG. 1 — Lineage of K121630, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (15)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K994121Small Stature Uss
Summary page 1
…3070) Device Product Code: OSH, MNI, MNH, KWP Regulatory Class: ' Class [1 3. Predicate or legally marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111…
Synthes (Usa)2000—
*K082572Uss Iliosacral, Uss Polyaxial
Summary page 1
…ice Product Code: OSH, MNI, MNH, KWP Regulatory Class: ' Class [1 3. Predicate or legally marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l…
Synthes Spine2008—
*K071668Orthobiom Spinal System
Summary page 1
…egulatory Class: ' Class [1 3. Predicate or legally marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Ort…
Paradigm Spine2008—
*K091445CD Horizon Spinal System
Summary page 1
…redicate or legally marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K12…
Medtronic Sofamor Danek2010—
*K102555CD Horizon Spinal System
Summary page 1
…or legally marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4.…
Medtronic Sofamor Danek USA, Inc.2010—
*K102807CD Horizon Spinal System
Summary page 1
…y marketed devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Descript…
Medtronic Sofamor Danek, Inc.2010—
*K110070TSRH Spinal System
Summary page 1
…d devices which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of th…
Medtronic Sofamor Danck USA, Inc.2011—
*K111942TSRH Spinal Systems
Summary page 1
…which are substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device…
Medtronic Sofamor Danek USA, Inc.2011—
*K111457CD Horizon Spinal System
Summary page 1
…re substantially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Ran…
Medtronic Sofamor Danek2011—
*K111510CD Horizon Spinal System
Summary page 1
…ntially equivalent : e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Range Spinal…
Medtronic Sofamor Danek, Inc.2011—
Kept off the family treeK112555FDA’s K112555 is CD Horizon (R) Spinal System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Medtronic Sofamor Danek USA, Inc.2011—
*K112473CD Horizon Spinal System
Summary page 1
…: e Synthes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Range Spinal System is a top-l…
Medtronic Sofamor Danek, Inc.2011—
*K113174CD Horizon Spinal System
Summary page 1
…thes USS (K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Range Spinal System is a top-loading, m…
Medtronic Sofamor Danek USA, Inc.20111
*K113529CD Horizon Voyager Spinal System
Summary page 1
…(K994121, K082572) ¢ Paradigm Spine Orthobium (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Range Spinal System is a top-loading, multlple c…
Medtronic Sofamor Danek2012—
*K120291OP Spine System
Summary page 1
…m (K071668) » Medtronic CD Horizon (K091445, K102555, K102807, K110070, 111942, K111457, K111510, K| l2555 K112473, K113174, K113529) o Orthopediatrics OP Spine System (K120291) 4. Description of the device: The Range Spinal System is a top-loading, multlple component, posterior (thoracic-lumbar) spinal…
OrthoPediatrics Corp.2012—

Also cleared against K994121: 12 other devices →

What descends from it? (127)

See all 127

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130932Firebird Spinal Fixation SystemOrthofix, Inc.201381
K132757Everest Spinal SystemK2m, Inc.201341
K130330Range Spinal SystemK2m, Inc.201336
K131784Range Spinal SystemK2m, Inc.201334
K122877Range Spinal System, Small StatureK2m, Inc.201334
K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334
K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433
K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430
K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415
K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 18 of the 152 ancestors have a recall of any class.
  • Of its descendants, K130932 (Orthofix, Inc., 2013) has gone furthest, with 81 descendants of its own.
  • 12 other devices also cite its predicate K994121.

How does its category compare?

All OSH devices

OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OSH

1in 2016

2012: 32013: 142014: 12016: 1
2007high 14 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OSH

82in 2013

2012: 76 days median2013: 82 days median
2007high 82 (2013) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OSH

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OSH

3in 2025

2009: 12011: 12012: 12013: 22014: 12015: 32016: 92017: 42018: 142019: 122020: 122021: 22022: 82023: 182024: 122025: 3
2007high 18 (2023) · low 0 (2007)2025

MAUDE reports naming product code OSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—01
201237601
2013148202
20141—01
20150—03
20161—09
20170—14
20180—014
20190—012
20200—012
20210—02
20220—08
20230—018
20240—012
20250—03
20260—0—

What is it indicated for?

RANGE/ DENALY MESA and ARI are cleared for the following 'indicatipns: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the…

Read the full statement (231 words)

RANGE/ DENALY MESA and ARI are cleared for the following 'indicatipns:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment ofa solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletaily mature patients, for the following indications: degenerative disc disease (DDD ) (défined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System .is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K994121

12 other devices cite the same predicate.

  • K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC · 2023
  • K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC · 2018
  • K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 20131 recall
  • K113666Xia 3 Spinal SystemStryker Spine · 2012
  • K121342Xia 4.5 Spinal SystemStryker Corp. · 2012
  • K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in OSH

The OSH category page

  • K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical · 2016
  • K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  • K132574Pass LP Spinal SystemMedicrea International · 2013
  • K132303Implanet Spine SystemImplanet, S.A. · 2013
  • K132575Pass LP Spinal SystemMedicrea International · 2013

https://510kreport.com/device/K121630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121630: Range Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121630

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026