Identity
- Trade Name
- REDAPT FDA UDI
- Generic Name
- Sleeve femoral/tibial extension, coated FDA UDI
- Device Name
- REDAPT MODULAR SLEEVE SMALL SIZE 20-21 STIKTITE WITH HYDROXYAPATITE FDA UDI
- Model / Reference
- 71354035 FDA UDI
- Description
- REDAPT MODULAR SLEEVE SMALL SIZE 20-21 STIKTITE WITH HYDROXYAPATITE FDA UDI
Identifiers
- Catalog Number
- 71354035 FDA UDI
- Primary DI / UDI-DI
- 03596010620606 FDA UDI
- 510(k) Number
- K081124 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Sleeve femoral/tibial extension, coated 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, coated
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
K081124 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.
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 612fad25-e30e-4fa2-8a97-1a85a3969615 36 fields · synced Jun 8, 2026