The Gecko Spinal System
FDA 510(k) K200281 · Ortho Development Corporation
510(k) numberK200281
Submission
- Device name
- The Gecko Spinal System
- Applicant
- Ortho Development Corporation
Draper, UT, US - Received
- February 4, 2020
- Decision date
- March 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWI – Bone Fixation Cerclage, Sublaminar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
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|---|---|---|---|
| K261374 | LigaPASS SystemOWI · Special | Medicrea International S.A.S | 05/27/2026SE |
| K253615 | Invictus Bands SystemOWI · Traditional | Alphatec Spine, Inc. | 03/25/2026SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | Astura Medical | 05/04/2023SE |
| K230565 | HILINE Fixation SystemOWI · Traditional | Globus Medical, Inc. | 04/20/2023SE |
| K213659 | LigaPASS 2.0 Ligament Augmentation SystemOWI · Traditional | Medicrea International SA | 05/24/2022SE |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal SystemOWI · Traditional | Medtronic, Inc. | 05/27/2021SE |
| K201240 | Mariner Cap SystemOWI · Traditional | SeaSpine Orthopedics Corporation | 08/05/2020SE |
| K200097 | Response BandLoc Spinal FixationOWI · Traditional | OrthoPediatrics Corp. | 03/16/2020SE |
| K191217 | Jazz PFOWI · Traditional | Implanet, S.A. | 08/02/2019SE |
| K190289 | Karma® Fixation SystemOWI · Traditional | Spinal Elements, Inc. | 04/03/2019SE |
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| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
| K211471 | Balanced Knee System UniHSX · Traditional | 12/16/2021SE |
| K203023 | Pisces Spinal SystemNKB · Traditional | 07/14/2021SE |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone AugmentsJWH · Traditional | 10/31/2018SE |
Questions and answers
When was The Gecko Spinal System cleared by the FDA?
The Gecko Spinal System (K200281) received a 510(k) decision of Substantially Equivalent on March 31, 2020, 56 days after the submission was received.
What is the product code of K200281?
The FDA product code is OWI – Bone Fixation Cerclage, Sublaminar, a Class II (moderate risk) device regulated under 21 CFR 888.3010.