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MiniMAX Stems 01.13.109R

by Medacta International

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 Number07630971238800 UDI-DI Date9 Mar 2020ListedStatusListed 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  • Withdrawn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
MiniMAX Stems
Generic Name
Press-fit hip femur prosthesis, one-piece
Model / Reference
01.13.109R
Primary DI / UDI-DI
07630971238800
510(k) Number
FDA Product Code
LZO, MEH, KWY, LZY
GMDN Term
Press-fit hip femur prosthesis, one-piece
Device Class
Class II
Regulation Number
888.3353, 888.3390, 888.3360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Press-fit hip femur prosthesis, one-piece

Cleared under the same submission (K192352)

Cleared under the same submission (K250450)

Show all (12)

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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