Cartiva SCI instrumentation set— 510(k) K192156
Substantially EquivalentCartiva, Inc.
FDA 510(k) clearance K192156 for Cartiva SCI instrumentation set, Substantially Equivalent on 2019-09-04. Applicant: Cartiva, Inc.. Device class: 2.
Clearance details
- Applicant
- Cartiva, Inc.
- Product code
- Code QBO
- Device class
- Class 2
- Regulation
- 21 CFR 888.4505
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alpharetta, GA, US
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