Identifiers
- 510(k) Number
- K200281 FDA 510(k)
- FDA Product Code
- OWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3010 FDA 510(k)
- Regulation Number
- 888.3010 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gecko Spinal System is a bone fixation cerclage, sublaminar device intended for temporary stabilization as a bone anchor during the development of solid bony fusion and to aid in the repair of bone fractures. It is classified under regulation number 888.3010 with product code OWI and device class 2.
The system received FDA 510(k) clearance under K200281 on March 31, 2020, following a traditional review process. It is manufactured by Ortho Development Corporation and is supplied as a temporary implant for use in orthopedic surgery.
Frequently asked questions
What is the Gecko Spinal System intended for?
The Gecko Spinal System is a bone fixation cerclage, sublaminar device intended for temporary stabilization as a bone anchor during the development of solid bony fusion and to aid in the repair of bone fractures. It is not intended for permanent implantation or load-bearing applications.
How is the Gecko Spinal System supplied and is it reusable?
The Gecko Spinal System is supplied as a temporary implant for use in orthopedic surgery. It is designed for single-use only and is not intended to be cleaned, resterilized, or reused after initial implantation due to risks of material degradation and infection.
What regulatory pathway was used for the Gecko Spinal System and when was it cleared?
The Gecko Spinal System received FDA 510(k) clearance under K200281 on March 31, 2020, following a traditional review process. It was found substantially equivalent to a predicate device and is classified as a Class II medical device under product code OWI and regulation 888.3010.
What classification and product code apply to the Gecko Spinal System?
The Gecko Spinal System is classified as a Class II medical device with product code OWI and regulation number 888.3010. It falls under the medical specialty of Orthopedic and is categorized as a bone fixation cerclage, sublaminar device.
Who manufactures the Gecko Spinal System and where is it located?
The Gecko Spinal System is manufactured by Ortho Development Corporation, located at 12187 S. Business Park Dr., Draper, UT 84020, United States. The manufacturer’s FEI number is 3003935342, as listed in the device registration details.
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: The Gecko Spinal System (K200281) — FDA 510(k) | Innolitics, The Gecko Spinal System — FDA 510 (k) K200281 | MedTracker, K200281 - The Gecko Spinal System FDA 510 (k) APPLICATION FOR Ortho ..., PDF The Gecko Spinal System 510 (k) K200281 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200281 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho Development Corporation
Sources (1)
- FDA 510(k) K200281 24 fields · synced Sep 19, 2026