Identity
- Trade Name
- SPATIAL FRAME FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- HEX FIX SET SCREW FDA UDI
- Model / Reference
- 112727 FDA UDI
- Description
- HEX FIX SET SCREW FDA UDI
Identifiers
- Catalog Number
- 112727 FDA UDI
- Primary DI / UDI-DI
- 23596010042396 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
MR Conditional FDA UDI
Category: External orthopaedic fixation system, reusable
Spatial Frame 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.
K994143 also covers:
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- CALANDRUCCIO II — 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 4d45d896-4eb0-491e-bea0-ace43d55d83b 36 fields · synced Jun 8, 2026