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STERIZO Total Hip System Rev A

by CPM Medical Consultants, LLC 244 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberB565M221554281 UDI-DI Date15 Feb 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
STERIZO Total Hip System
Generic Name
Metallic femoral head prosthesis
Model / Ref / Catalog
Rev A, M-2215-5428
Primary DI / UDI-DI
B565M221554281
510(k) Number
FDA Product Code
LPH, LZO
GMDN Term
Metallic femoral head prosthesis
Device Class
Class II
Regulation Number
888.3358, 888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metallic femoral head prosthesisMetal-on-polyethylene total hip prosthesis

Cleared under the same submission (K143314)

Show all (12)

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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