The following data is part of a premarket notification filed by Cartiva, Inc. with the FDA for Cartiva Sci Disposable Instrumentation Set.
Device ID | K181348 |
510k Number | K181348 |
Device Name: | Cartiva SCI Disposable Instrumentation Set |
Classification | Instruments Designed For Press-fit Osteochondral Implants |
Applicant | Cartiva, Inc. 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
Contact | Tanya Eberle |
Correspondent | Tanya Eberle Cartiva, Inc. 6120 Windward Parkway Suite 220 Alpharetta, GA 30005 |
Product Code | QBO |
CFR Regulation Number | 888.4505 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-21 |
Decision Date | 2018-06-20 |
Summary: | summary |