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Na 47-2357-008-14

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024088375 UDI-DI Date28 Sep 2017ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0316-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0311-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0309-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0310-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
47-2357-008-14
Primary DI / UDI-DI
00889024088375
510(k) Number
FDA Product Code
HRS, HWC
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
Size
Length — 216 Millimeter

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K050121)

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Cleared under the same submission (K111039)

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Other devices from Zimmer, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No