Identity
- Trade Name
- Shoulder Innovations InSet 70 Humeral Stem FDA UDI
- Generic Name
- Total shoulder prosthesis FDA UDI
- Device Name
- Shoulder Innovations - InSet 70 Humeral Stem - 4x70mm FDA UDI
- Model / Reference
- 4x70mm FDA UDI
- Description
- Shoulder Innovations - InSet 70 Humeral Stem - 4x70mm FDA UDI
Identifiers
- Catalog Number
- 2L1S040000 FDA UDI
- Primary DI / UDI-DI
- B1132L1S0400000 FDA UDI
- FDA Product Code
- MBF FDA UDIHSD FDA UDIKWT FDA UDIKWS FDA UDI
- GMDN Term
- Total shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3670 FDA UDI888.3690 FDA UDI888.3650 FDA UDI888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Total shoulder prosthesisCoated shoulder humeral stem prosthesis
Shoulder Innovations InSet 70 Humeral Stem by SHOULDER INNOVATIONS, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coated shoulder humeral stem prosthesis.
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- INHANCE — DEPUY (IRELAND) · Class II
- Aequalis™ PerFORM+ — TORNIER, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SHOULDER INNOVATIONS, Inc
Sources (1)
- FDA UDI 98ce6cf4-d41c-4bc2-8f38-92d7f5c1eb2c 35 fields · synced May 29, 2026