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Biolox 18-28-3

by Howmedica Osteonics Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number07613154166527 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Biolox
Generic Name
Ceramic femoral head prosthesis
Model / Ref / Catalog
18-28-3
Primary DI / UDI-DI
07613154166527
FDA Product Code
LZO
GMDN Term
Ceramic femoral head prosthesis
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 28.0 Millimeter

Related devices

Category: Ceramic femoral head prosthesis

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

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

Other properties (9)

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