The following data is part of a premarket notification filed by Medacta International with the FDA for Versafitcup Cc Trio-additional Liners.
Device ID | K120531 |
510k Number | K120531 |
Device Name: | VERSAFITCUP CC TRIO-ADDITIONAL LINERS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Contact | Adam Gross |
Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-22 |
Decision Date | 2012-04-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630030807671 | K120531 | 000 |
07630030807541 | K120531 | 000 |