Identity
- Trade Name
- REDAPT FDA UDI
- Generic Name
- Sleeve femoral/tibial extension, uncoated FDA UDI
- Device Name
- REDAPT MODULAR SLEEVE 12-13 EXTRA SMALL GRIT-BLASTED FINISH FDA UDI
- Model / Reference
- 71354213 FDA UDI
- Description
- REDAPT MODULAR SLEEVE 12-13 EXTRA SMALL GRIT-BLASTED FINISH FDA UDI
Identifiers
- Catalog Number
- 71354213 FDA UDI
- Primary DI / UDI-DI
- 00885556254219 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Sleeve femoral/tibial extension, uncoated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Sleeve femoral/tibial extension, uncoated
Redapt by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sleeve femoral/tibial extension, uncoated.
- Pantheon System — ADLER ORTHO SPA · Class II
- Tibial Stem Extension Reamer — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Pantheon System — ADLER ORTHO SPA · Class II
- Pantheon System — ADLER ORTHO SPA · Class II
- MUTARS® extension piece — implantcast GmbH · Class II
- MUTARS® connecting part — implantcast GmbH · Class II
- EXULT Knee Replacement System — Corentec Co., Ltd · Class II
- Pantheon System — ADLER ORTHO SPA · Class II
Cleared under the same submission
K100481 also covers:
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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 12c335aa-ae2f-4afd-a9b4-b9b41e1b27c0 36 fields · synced Jun 8, 2026