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Aequalis™ Flex Revive™ ARS655119

by Tornier, Inc.

Aequalis™ Flex Revive™ ARS655119 is a Class II device made by Tornier, Inc., listed in FDA GUDID since 4 Mar 2019 (UDI-DI 00846832072279), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846832072279 UDI-DI Date4 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Aequalis™ Flex Revive™
Generic name
Shoulder prosthesis screw
Model / Ref / Catalog
ARS655119
Primary DI / UDI-DI
00846832072279
FDA product code
HSD, KWS, PHX
GMDN term
Shoulder prosthesis screw
Device class
Class II
Regulation number
888.3690, 888.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Shoulder prosthesis screw

Similar devices in this category

Other devices filed under Shoulder prosthesis screw.

Other devices from Tornier, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)