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Htr-Pmi PM618851

by Biomet Microfixation, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number00841036224189 UDI-DI Date13 Dec 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2751-2016 FDA Class II initiated 13 Jun 2016

    Potential sterility deficiency.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Htr-Pmi
Generic Name
Cranioplasty plate, non-alterable
Model / Reference
PM618851
Primary DI / UDI-DI
00841036224189
510(k) Number
FDA Product Code
LZK, KKY, FZE, FWP
GMDN Term
Cranioplasty plate, non-alterable
Device Class
Class II
Regulation Number
878.3550, 878.3500, 878.3680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cranioplasty plate, non-alterable

Cleared under the same submission (K924935)

Show all (12)

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

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