Shoulder Innovations InSet 95 Humeral Stem Low Profile Lever Lock Broach Handle
Listed
Valid until
Not applicable
FDA recalls
None foundDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB1132A2HI000100 | Date28 May 2026 | StatusListed |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Shoulder Innovations InSet 95 Humeral Stem
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- Low Profile Lever Lock Broach Handle, 2A2HI00010
- Primary DI / UDI-DI
- B1132A2HI000100
- FDA Product Code
- MBF, HSD, KWT, KWS
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Class
- Class II
- Regulation Number
- 888.3670, 888.3690, 888.3650, 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from SHOULDER INNOVATIONS, Inc
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No