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Shoulder Innovations InSet FxR 135 4mmX135

by SHOULDER INNOVATIONS, 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 NumberB1132L1S0400020 UDI-DI Date12 Dec 2025ListedStatusListed 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  • Withdrawn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
Shoulder Innovations InSet FxR 135
Generic Name
Total shoulder prosthesis
Model / Ref / Catalog
4mmX135, 2L1S040002
Primary DI / UDI-DI
B1132L1S0400020
FDA Product Code
KWT, PHX, MBX, KWS, HSD
GMDN Term
Total shoulder prosthesis
Device Class
Class II
Regulation Number
888.3650, 888.3660, 888.3690
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • 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