Identity
- Trade Name
- REDAPT FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- REDAPT DISTAL REAMER 240MM SIZE 15.5 FDA UDI
- Model / Reference
- 71355012 FDA UDI
- Description
- REDAPT DISTAL REAMER 240MM SIZE 15.5 FDA UDI
Identifiers
- Catalog Number
- 71355012 FDA UDI
- Primary DI / UDI-DI
- 00885556219393 FDA UDI
- 510(k) Number
- K121627 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
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
K121627 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 c32b4ad3-ce36-4eef-b614-3613290b4621 36 fields · synced Jun 8, 2026