Identity
- Trade Name
- Kyocera Medical Technologies, Inc. FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- CR Tibial Insert Trial with Posterior Pin Relief, Size A Left 10mm FDA UDI
- Model / Reference
- A200 FDA UDI
- Description
- CR Tibial Insert Trial with Posterior Pin Relief, Size A Left 10mm FDA UDI
Identifiers
- Catalog Number
- 2204-131-110 FDA UDI
- Primary DI / UDI-DI
- 00841523172320 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
FDA UDI
Single Use
No
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
Yes
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: General internal orthopaedic fixation system implantation kit
A comprehensive medical device that provides a collection of instruments and devices intended for the placement of an internal orthopaedic fixation system into or onto various bones.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Kyocera Medical Technologies, Inc.
Sources (1)
- FDA UDI 2451cc9e-7894-4e1e-8e47-0d43861f2dda 34 fields · synced Jul 24, 2026