Identity
- Trade Name
- HEX-FIX FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- TITANIUM HALF PIN 5.0MM X 50MM FDA UDI
- Model / Reference
- 122713 FDA UDI
- Description
- TITANIUM HALF PIN 5.0MM X 50MM FDA UDI
Identifiers
- Catalog Number
- 122713 FDA UDI
- Primary DI / UDI-DI
- 03596010069474 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Hex-Fix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, non-bioabsorbable.
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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.
K920024 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 2f63f0e6-5543-4140-a483-bb8986b6aeaf 36 fields · synced Jun 8, 2026