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Mrs 6487-1-040

by Howmedica Osteonics Corp.

Mrs 6487-1-040 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K954559 on 12 Jul 1996 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613327048940), active as of 23 Oct 2026.

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

510(k) K954559

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327048940 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK954559 Date12 Jul 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K954559 decided 12 Jul 1996 Active
  • FDA GUDID UDI-DI 07613327048940 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K954559
  2. Listed FDA GUDID 07613327048940

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mrs
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
6487-1-040
Primary DI / UDI-DI
07613327048940
510(k) Number
FDA product code
HSD
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class II
Regulation number
888.3690
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)