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P.F.C. 86-6404

by Depuy (Ireland)

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

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 StatesFDA 510(k) from GUDID NumberK241000 Date11 Jul 2024IssuedStatusActive
United StatesGUDID listing Number10603295216926 UDI-DI Date24 Sep 2015ListedStatusListed 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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
P.F.C.
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
86-6404, 866404
Primary DI / UDI-DI
10603295216926
510(k) Number
FDA product code
JWH
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • 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