Identity
- Trade Name
- Kyocera Medical Technologies, Inc. FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Short Femoral Sizer 3 Deg Feet, Left FDA UDI
- Model / Reference
- A 200 FDA UDI
- Description
- Short Femoral Sizer 3 Deg Feet, Left FDA UDI
Identifiers
- Catalog Number
- 2202-111-003 FDA UDI
- Primary DI / UDI-DI
- 00841523147892 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General internal orthopaedic fixation system implantation kit
The General Internal Orthopaedic Fixation System Implantation Kit is a comprehensive collection of instruments and devices designed for the placement of internal orthopaedic fixation systems into or onto various bones, including limbs, spine, pelvis, or craniomaxillofacial. This reusable device includes metallic and/or plastic instruments such as retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors, which are intended for implanting any type of internal orthopaedic fixation system. It is used in non-dedicated devices and is not included with the implant(s). The device is available for commercial distribution and has been certified as part of a 200-series product line.
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
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- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kyocera Medical Technologies, Inc.
Sources (1)
- FDA UDI 70be5f4b-a9ce-4b5e-b5d8-a870d61569df 34 fields · synced Jul 24, 2026