Identity
- Trade Name
- HEX-FIX FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- HEX FIX BAR END CAP FDA UDI
- Model / Reference
- 112728 FDA UDI
- Description
- HEX FIX BAR END CAP FDA UDI
Identifiers
- Catalog Number
- 112728 FDA UDI
- Primary DI / UDI-DI
- 23596010042402 FDA UDI
- FDA Product Code
- LXT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Hex-Fix 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
K201253 also covers:
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
K953397 also covers:
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — 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 28641711-f613-4da5-b699-b05e5ff28108 36 fields · synced Jun 8, 2026