Identity
- Trade Name
- HEX-FIX FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- HEX-FIX METATARSAL PADDLE & CLAMP FDA UDI
- Model / Reference
- 112709 FDA UDI
- Description
- HEX-FIX METATARSAL PADDLE & CLAMP FDA UDI
Identifiers
- Catalog Number
- 112709 FDA UDI
- Primary DI / UDI-DI
- 03596010042231 FDA UDI
- FDA Product Code
- LXT FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable 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
No
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
Category: External orthopaedic fixation system, reusable
Hex-Fix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, reusable.
- HOFFMANN — Stryker Corp. · Class II
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- TransFx™ — Zimmer, Inc. · Class I
- HOFFMANN — Stryker Corp. · Class II
- SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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 319bd19a-9fa1-4396-a194-2d882390040f 36 fields · synced Jun 8, 2026