Identity
- Trade Name
- Identity Humeral FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Model / Reference
- 110047146 FDA UDI
Identifiers
- Catalog Number
- 110047146 FDA UDI
- Primary DI / UDI-DI
- 00889024691414 FDA UDI
- 510(k) Number
- K251098 FDA UDI
- FDA Product Code
- HSD FDA UDIPHX FDA UDIKWT FDA UDIKWS FDA UDIMBF FDA UDI
- GMDN Term
- Coated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 FDA UDI888.3650 FDA UDI888.3670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDI
Category: Coated shoulder humeral stem prosthesis
Identity Humeral by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated shoulder humeral stem prosthesis.
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Tornier HRS — TORNIER, INC. · Class II
- Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
- Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- Aequalis™ PerFORM+ — TORNIER, INC. · Class II
- Compress® Device — Biomet Orthopedics, Inc. · Class II
- Tornier Perform® Anatomic Augmented Glenoid — TORNIER, INC. · Class II
Cleared under the same submission
K251098 also covers:
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
- Identity Humeral — Zimmer, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 8a596a49-2a5d-4297-a521-ff59da05f1f6 36 fields · synced May 30, 2026