510(k) K181348
K181348 is an FDA 510(k) premarket notification submitted by Cartiva, Inc. for the device "Cartiva SCI Disposable Instrumentation Set". The FDA issued a decision of Substantially Equivalent on June 20, 2018. The device falls under product code QBO (Instruments Designed For Press-Fit Osteochondral Implants), a Class II device regulated under 21 CFR 888.4505. Cartiva, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2018
- Date Received
- May 21, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instruments Designed For Press-Fit Osteochondral Implants
- Device Class
- Class II
- Regulation Number
- 888.4505
- Review Panel
- OR
- Submission Type
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.