Identity
- Trade Name
- Profix FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- 3 DEGREE TIBIAL CUTTING BLOCK FDA UDI
- Model / Reference
- E0016236-1 FDA UDI
- Description
- 3 DEGREE TIBIAL CUTTING BLOCK FDA UDI
Identifiers
- Catalog Number
- E0016236-1 FDA UDI
- Primary DI / UDI-DI
- 00885556732359 FDA UDI
- 510(k) Number
- K121393 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 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: Osteotomy guide, reusable
Profix 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
K121393 also covers:
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GENESIS II — Smith & Nephew, Inc.
- GII — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- Genesis II — Smith & Nephew, Inc.
- IMHS — Smith & Nephew, Inc.
- JOURNEY — 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 f95b2d98-3bc4-4ad5-9740-f3baf9b9423d 36 fields · synced Jun 8, 2026