EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD - External Fixaton Clamp
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080408 FDA 510(k)
- FDA Product Code
- KTT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An external fixation clamp is a device used to secure pins and rods in an external fixation system for stabilizing bone fractures. This specific clamp is designed to accommodate a 5.0 mm pin and a 9.5 mm rod, as indicated in its model designation and specifications.
The device is supplied as a reusable component of an external fixation system, intended for use in orthopedic surgical settings. It received FDA 510(k) clearance under product code KTT with decision date April 25, 2008, and is identified by the model number 1151-100. No information regarding sterility, single-use status, MRI safety, storage conditions, or additional sizes is provided in the data.
Frequently asked questions
What is the External Fixation Clamp Model 1151-100 used for?
This clamp is used to secure pins and rods in an external fixation system to stabilize bone fractures, specifically accommodating a 5.0 mm pin and a 9.5 mm rod as indicated in its model designation and specifications.
Is the External Fixation Clamp Model 1151-100 reusable or single-use?
The device is supplied as a reusable component of an external fixation system, intended for repeated use in orthopedic surgical settings after appropriate cleaning and sterilization by the healthcare facility.
What regulatory pathway was used for the External Fixation Clamp Model 1151-100?
The device received FDA 510(k) clearance under product code KTT with decision date April 25, 2008, and k-number K080408, indicating it was found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL… - FDA.report, Small External Fixation System - Arthrex, ADVANCED ORTHOPAEDIC SOLUTIONS, INC. - fda.report, JET-X - Smith+Nephew Global
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080408 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA 510(k) K080408 24 fields · synced Sep 26, 2026