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ARROW® 265151 - CoCr GLENOSPHERE, Ø39

by Fournitures Hospitalieres Industrie

ARROW® 265151 - CoCr GLENOSPHERE, Ø39 is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K112193 on 12 Jul 2012 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 03661489651519), active as of 22 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 22 Oct 2026

Documents

510(k) K112193

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03661489651519 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112193 Date12 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112193 decided 12 Jul 2012 Active
  • FDA GUDID UDI-DI 03661489651519 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112193
  2. Listed FDA GUDID 03661489651519

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arrow®
Generic name
Total reverse shoulder prosthesis
Model / reference
265151 - CoCr GLENOSPHERE, Ø39
Primary DI / UDI-DI
03661489651519
510(k) Number
FDA product code
KWS, KWT
GMDN term
Total reverse shoulder prosthesis
Device class
Class II
Regulation number
888.3660, 888.3650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total reverse shoulder prosthesis

Cleared under the same submission (K112193)

and 8 more cleared under K112193

Similar devices

Other devices filed under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).

Other devices from Fournitures Hospitalieres Industrie

See all devices from Fournitures Hospitalieres Industrie →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)