FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Innovasis Gibralt Spine System
K Number: K192354
·
Decision Sep 24, 2019
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
33
Review Days
26
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Basic Information
- Device Name
- Innovasis Gibralt Spine System
- K Number
- K192354
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- August 29, 2019
- Decision Date
- September 24, 2019
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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