Identity
- Trade Name
- GLOBAL STEPTECH FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm LEFT CEMENTED FDA UDI
- Model / Reference
- 1130-44-105 FDA UDI
- Description
- GLOBAL STEPTECH APG PREMIERON X-LINKED PE SIZE 44 +5mm LEFT CEMENTED FDA UDI
Identifiers
- Catalog Number
- 113044105 FDA UDI
- Primary DI / UDI-DI
- 10603295005803 FDA UDI
- 510(k) Number
- K092122 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
Category: Shoulder glenoid fossa prosthesis, prefabricated
Global Steptech by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
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Cleared under the same submission
K092122 also covers:
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, INC.
- GLOBAL STEPTECH — DEPUY ORTHOPAEDICS, 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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI ec394fc9-0e13-4e94-b81f-dd8f413a5538 36 fields · synced Jun 8, 2026