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Mpact 3D Metal Foam 25070.3646HC

by Medacta International GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630542713637 UDI-DIDate4 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Mpact 3D Metal Foam
Generic Name
Polyethylene acetabulum prosthesis
Model / Reference
25070.3646HC
Primary DI / UDI-DI
07630542713637
510(k) Number
FDA Product Code
LPH
GMDN Term
Polyethylene acetabulum prosthesis
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253630)

Show all (12)

Other devices from Medacta International

See all devices from Medacta International →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

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