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Integral Centralizer Hip System 12-162613

by Biomet Orthopedics, 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 Number00880304223318 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0650-2016 FDA Class II initiated 17 Nov 2015

    PMMA is listed as a material on the label but the product does not contain PMMA.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Integral Centralizer Hip System
Generic Name
Uncoated femoral stem prosthesis, one-piece
Model / Ref / Catalog
12-162613
Primary DI / UDI-DI
00880304223318
510(k) Number
FDA Product Code
LZO, JDG
GMDN Term
Uncoated femoral stem prosthesis, one-piece
Device Class
Class II
Regulation Number
888.3353, 888.3360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated femoral stem prosthesis, one-piece

Cleared under the same submission (K942479)

Show all (12)

Other devices from Biomet Orthopedics, 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