Identity
- Trade Name
- REDAPT FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- REDAPT FULLY POROUS SHELL 64MM FDA UDI
- Model / Reference
- 71354237 FDA UDI
- Description
- REDAPT FULLY POROUS SHELL 64MM FDA UDI
Identifiers
- Catalog Number
- 71354237 FDA UDI
- Primary DI / UDI-DI
- 00885556321591 FDA UDI
- FDA Product Code
- JDI FDA UDILZO FDA UDILPH FDA UDIKWZ FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3353 FDA UDI888.3358 FDA UDI888.3310 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
MR Conditional FDA UDI
Category: Acetabular shell
Redapt by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150790 also covers:
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
- REDAPT — Smith & Nephew, Inc.
K211176 also covers:
- BUCK — Smith & Nephew, Inc.
- Conquest FX — Smith & Nephew, Inc.
- Contour — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 76790fed-b4b9-45c5-a759-8351fbf92d68 36 fields · synced Jun 8, 2026