510(k) Report

510(k) · Cleared

Cleared

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

K231636510(k) SpecialCleared Jun 27, 202322-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

L&K BIOMED Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 27, 2023 as substantially equivalent to K230245 (L&K BIOMED Co., Ltd., 2023) and 9 other predicates after a 22-day review. Its family tree reaches back 19 generations to 2004. 1 of the 329 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Jun 27, 2023
Review
22 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
10

Its longest line of descent runs back 19 generations to K040583 (2004). 326 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 329 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2022: 1 other ancestor2020: 2 other ancestors2019: 1 other ancestor2018: 1 other ancestor2017: 2 other ancestors2015: 3 other ancestors2012: 8 other ancestors2016: 4 other ancestors2013: 5 other ancestors2011: 10 other ancestors2010: 18 other ancestors, 1 with a Class I recall12009: 15 other ancestors2008: 17 other ancestors2007: 15 other ancestors2006: 21 other ancestors2003: 18 other ancestors2001: 23 other ancestors2000: 22 other ancestors1998: 11 other ancestors1997: 7 other ancestors1996: 5 other ancestors1995: 7 other ancestors1992: 5 other ancestors2005: 26 other ancestors2004: 23 other ancestors2002: 14 other ancestors1999: 10 other ancestors1994: 2 other ancestors1993: 3 other ancestors1990: 2 other ancestors2014: 3 other ancestors1978: 1 other ancestor1984: 1 other ancestor1985: 1 other ancestor2023: 1 descendant cleared2026: 1 descendant 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) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K181139 · OLYMPIC Posterior Spinal Fixation System · Astura Medical, LLC · 2018K230245 · LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System · L&K BIOMED Co., Ltd. · 202319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 37 other ancestors, 1 with a Class I recall13 generations back: 75 other ancestors4 generations back: 75 other ancestors5 generations back: 56 other ancestors6 generations back: 21 other ancestors7 generations back: 18 other ancestors8 generations back: 16 other ancestors9 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K230245 · LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System · L&K BIOMED Co., Ltd. · 2023K181139 · OLYMPIC Posterior Spinal Fixation System · Astura Medical, LLC · 2018K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · 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 · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  4. 2 generations backK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  5. 1 generation backK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  6. This deviceK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  7. Descendant · cites it directly · 1 of its ownK232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  8. Descendant · 2 generations on · 0 of its ownK261130 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 5 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 4 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 2 generations backK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  19. 1 generation backK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  20. This deviceK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly1descendant
  • K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−3K142381Xia 3 Spinal SystemStryker Corp.2014—
−2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018—
−1K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
0 (this device)K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+1K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199420
199570
199650
199770
1998110
1999100
2000220
2001230
2002140
2003180
2004230
2005260
2006210
2007150
2008170
2009150
2010181
2011100
201280
201350
201430
201530
201640
201720
201810
201910
202020
202210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202610
FIG. 1 — Lineage of K231636, 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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…
Summary page 5
…ntific technology, and indications for use. LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System Primary Predicate Device: LnK Spinal Fixation System (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…
L&K BIOMED Co., Ltd.2023—
*K120270Venus Spinal Fixation System
Summary page 5
…: LnK Spinal Fixation System (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K18113…
L&K BIOMED Co., Ltd.2012—
*K143363VENUS Spinal Fixation System
Summary page 5
…nal Fixation System (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) A…
L&K BIOMED Co., Ltd.2015—
*K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
Summary page 5
…ion System (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) AccelFix S…
L&K BIOMED Co., Ltd.2017—
*K183168OpenLoc-L Spinal Fixation System
Summary page 5
…m (K230245) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) AccelFix Spinal Fix…
L&K BIOMED Co., Ltd.2018—
*K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
Summary page 5
…5) Additional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) AccelFix Spinal Fixation Syst…
L&K BIOMED Co., Ltd.2020—
*K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…
Summary page 5
…ditional Predicate Devices: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) AccelFix Spinal Fixation System P…
L&K BIOMED Co., Ltd.2022—
*K181139OLYMPIC Posterior Spinal Fixation System
Summary page 5
…em (K120270, K143363, K171813, K183168, K 200790, K223565) Olympic Posterior Spinal Fixation System(K181139) AccelFix Spinal Fixation System Primary Predicate Device: AccelFix Spinal Fixation System (K182544) Additional Pr…
Astura Medical, LLC2018—
*K182544AccelFix Spinal Fixation System
Summary page 5
…Olympic Posterior Spinal Fixation System(K181139) AccelFix Spinal Fixation System Primary Predicate Device: AccelFix Spinal Fixation System (K182544) Additional Predicate Devices: AccelFix Spinal Fixation System (K200794, K223565, K230245)…
L&K BIOMED Co., Ltd.2019—
*K200794AccelFix Spinal Fixation System
Summary page 5
…elFix Spinal Fixation System Primary Predicate Device: AccelFix Spinal Fixation System (K182544) Additional Predicate Devices: AccelFix Spinal Fixation System (K200794, K223565, K230245) Olympic Posterior Spinal Fixation System(K181139)…
L&K BIOMED Co., Ltd.2020—

Also cleared against K230245: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 5 months on median.
  • 32 of the 326 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K232311 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K230245.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as…

Read the full statement (204 words)

The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

Indications for use as stated in the FDA summary.

Also cleared against K230245

1 other device cites the same predicate.

  • K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2023

More from L&K BIOMED Co., Ltd.

58 FDA decisions under this applicant name. See the company

  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
  • K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K231636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231636: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231636

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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