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Profemur® PRLX5813

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 NumberM684PRLX58131 UDI-DI Date20 Oct 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  • Withdrawn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
Profemur®
Generic Name
Coated femoral stem prosthesis, modular
Model / Ref / Catalog
PRLX5813
Primary DI / UDI-DI
M684PRLX58131
FDA Product Code
LZO, MBL
GMDN Term
Coated femoral stem prosthesis, modular
Device Class
Class II
Regulation Number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated femoral stem prosthesis, modular

Other devices from MicroPort Orthopedics Inc.

See all devices from MicroPort Orthopedics Inc. →

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