510(k) Report

510(k) · Cleared

Cleared

EZ Plate

K173306510(k) TraditionalCleared Jan 22, 201896-day reviewClass II21 CFR 888.3060

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

Zavation Medical Products, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 22, 2018 as substantially equivalent to K112533 (Zavation, LLC, 2011) and 3 other predicates after a 96-day review. Its family tree reaches back 6 generations to 1995.

Decided
Jan 22, 2018
Review
96 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K953730 (1995). 19 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors2007: 2 other ancestors2006: 1 other ancestor2004: 2 other ancestors1997: 1 other ancestor1998: 1 other ancestorK953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalled199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 2 other ancestors5 generations back: 1 other ancestor K133518 · Maxan Anterior Cervical Plate System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK080646 · C-Tek Maxan Anterior Cervical Plate System · Biomet Spine · 2008 · recalledK072546 · Swift Plus Anterior Cervical Plate System · Depuy Spine, Inc. · 2007K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
  6. 1 generation backK133518 Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  7. This deviceK173306 EZ PlateZavation Medical Products, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−5K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−4K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
−3K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
−2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082
−1K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC)20141
0 (this device)K173306EZ PlateZavation Medical Products, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200030
200220
200420
200610
200720
201110
FIG. 1 — Lineage of K173306, 1995–2018Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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? (4)

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
*K112533Zavation Cervical Plate System
Summary page 5
…, QBHFPG Primary Predicate Device: K112533 Zavation Cervical Plate System Additional Predicate Devices: K133518 Biomet MaxAn K021761 Medtronic Premier Plate K001794 EBI Ce…
Zavation, LLC2011—
*K133518Maxan Anterior Cervical Plate System
Summary page 5
…QBHFPG Primary Predicate Device: K112533 Zavation Cervical Plate System Additional Predicate Devices: K133518 Biomet MaxAn K021761 Medtronic Premier Plate K001794 EBI Cervical Plate System Technological Characteristics: The EZ Plate™ cerv…
Biomet Spine (Aka Ebi, LLC)20141
*K021761Premier Anterior Cervical Plate System
Summary page 5
…QBHFPG Primary Predicate Device: K112533 Zavation Cervical Plate System Additional Predicate Devices: K133518 Biomet MaxAn K021761 Medtronic Premier Plate K001794 EBI Cervical Plate System Technological Characteristics: The EZ Plate™ cervical plate system pos…
Medtronic Sofamor Danek2002—
*K001794Ebi Anterior Cervical Plate System
Summary page 5
…QBHFPG Primary Predicate Device: K112533 Zavation Cervical Plate System Additional Predicate Devices: K133518 Biomet MaxAn K021761 Medtronic Premier Plate K001794 EBI Cervical Plate System Technological Characteristics: The EZ Plate™ cervical plate system possesses the same technological ch…
Ebi, L.P.2000—

Also cleared against K112533: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 23 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K112533.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The EZ Plate™ cervical plate system is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.c., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

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 K112533

4 other devices cite the same predicate.

  • K181244Zavation Cervical Plate SystemZavation Medical Products, LLC · 2018
  • K180537Zavation Buttress Plate SystemZavation Medical Products, LLC · 2018
  • K150666uNion Cervical Plate SystemUlrich Medical USA · 20151 recall
  • K130030Zavation Cervical Plate SystemZavation, LLC · 2013

More from Zavation Medical Products, LLC

31 FDA decisions under this applicant name. See the company

  • K253943Tiger 2 SystemZavation Medical Products, LLC · 2026
  • K243908Tiger 2 SystemZavation Medical Products, LLC · 2025
  • K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation…Zavation Medical Products, LLC · 2024
  • K231811Zavation Connector SystemZavation Medical Products, LLC · 2023
  • K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC · 2023

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K173306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173306: EZ Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173306

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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