Synthes Usa Hybrid External Fixator Modifications
510(k) K073135
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073135 | Date29 Jan 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LXT
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Synthes Usa Hybrid External Fixator Modifications is an orthopedic appliance, fixation, nail/blade/plate combination, multiple component, metal composite device. It is part of the Synthes Hybrid External Fixator system, which is used for fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.
The device is supplied with various components and is regulated under the product code LXT, with a regulation number of 888.3030. It has been cleared by the FDA under the traditional clearance type, with a decision code of SESE. The device is intended for use in orthopedic applications, specifically for the fixation of tibial fractures.
Other devices from Synthes (Usa)
Questions
AI-generated answers, 21 Sep 2026
What is the Synthes Hybrid External Fixator Modifications used for?
The Synthes Hybrid External Fixator Modifications is used for fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft, as part of the Synthes Hybrid External Fixator system, which is an orthopedic appliance.
What type of device is the Synthes Hybrid External Fixator Modifications?
The Synthes Hybrid External Fixator Modifications is a metal composite device, classified as an orthopedic appliance, fixation, nail/blade/plate combination, multiple component.
How is the Synthes Hybrid External Fixator Modifications supplied?
The device is supplied with various components as part of the Synthes Hybrid External Fixator system.
What is the regulatory classification of the Synthes Hybrid External Fixator Modifications?
The device is regulated under the product code LXT, with a regulation number of 888.3030, and has been cleared by the FDA under the traditional clearance type.