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MicroPort MALLET

by MicroPort Orthopedics Inc.

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 NumberM684MALLET1 UDI-DI Date7 Mar 2017ListedStatusListed 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  • Withdrawn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
MicroPort
Generic Name
Joint prosthesis implantation kit, reusable
Model / Ref / Catalog
MALLET
Primary DI / UDI-DI
M684MALLET1
FDA Product Code
HXL
GMDN Term
Joint prosthesis implantation kit, reusable
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Joint prosthesis implantation kit, reusable

Other devices from MicroPort Orthopedics Inc.

See all devices from MicroPort Orthopedics Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No