Identity
- Trade Name
- INHANCE FDA UDI
- Generic Name
- Reverse shoulder prosthesis base plate FDA UDI
- Device Name
- INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE LARGE Ø29mm CEMENTLESS FDA UDI
- Model / Reference
- 5500-11-290 FDA UDI
- Description
- INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE LARGE Ø29mm CEMENTLESS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10603295553205 FDA UDI
- FDA Product Code
- PAO FDA UDIHSD FDA UDIKWT FDA UDIPKC FDA UDIMBF FDA UDIPHX FDA UDIKWS FDA UDI
- GMDN Term
- Reverse shoulder prosthesis base plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI888.3650 FDA UDI888.3670 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Reverse shoulder prosthesis base plate
Inhance by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis base plate.
- AGILON® XO glenoid cementless cpTi — implantcast GmbH · Class II
- Glenoid Reconstruction System — Medacta International · Class II
- Titan™ — Ascension Orthopedics, Inc. · Class II
- AEQUALIS™ PerFORM+ Reversed — TORNIER, INC. · Class II
- Tornier Perform® Reversed Augmented Glenoid — TORNIER, INC. · Class II
- REUNION — Stryker Corp. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
Cleared under the same submission
K212737 also covers:
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
- INHANCE — DEPUY (IRELAND)
K230831 also covers:
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
- Depuy (ireland)
Sources (1)
- FDA UDI 593e5109-31cd-4c95-b064-3b0b38f5c0ec 35 fields · synced Jun 8, 2026