FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Gecko Spinal System
K Number: K200281
·
Decision Mar 31, 2020
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
14
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- The Gecko Spinal System
- K Number
- K200281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Development Corporation
- Date Received
- February 4, 2020
- Decision Date
- March 31, 2020
- Product Code
- OWI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWI), ordered by most recent decision date.
LigaPASS System
FDA 510(k)
FDA Class 2
·Orthopedic
Invictus Bands System
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPIC Deformity Band System
FDA 510(k)
FDA Class 2
·Orthopedic
HILINE Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LigaPASS 2.0 Ligament Augmentation System
FDA 510(k)
FDA Class 2
·Orthopedic
LigaPASS® Spinal System, CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Ortho Development Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Oct 25, 2023 | Substantially Equivalent |
| K211086 | The Progen Trochanteric Nail System | Dec 21, 2021 | Substantially Equivalent |
| K211471 | Balanced Knee System Uni | Dec 16, 2021 | Substantially Equivalent |
| K203023 | Pisces Spinal System | Jul 14, 2021 | Substantially Equivalent |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Oct 31, 2018 | Substantially Equivalent |
| K181569 | BKS Revision Sleeves System | Oct 12, 2018 | Substantially Equivalent |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Jun 20, 2018 | Substantially Equivalent |
| K173951 | Legend Acetabular Liners | May 30, 2018 | Substantially Equivalent |
| K171249 | Entrada hip stem | Aug 24, 2017 | Substantially Equivalent |
| K162995 | Ibis® Pedicle Screw System | Mar 30, 2017 | Substantially Equivalent |