The following data is part of a premarket notification filed by Medacta International with the FDA for Versafitcup Cc Trio Extension.
| Device ID | K122911 |
| 510k Number | K122911 |
| Device Name: | VERSAFITCUP CC TRIO EXTENSION |
| 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 | 2012-09-21 |
| Decision Date | 2012-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030807954 | K122911 | 000 |
| 07630030807725 | K122911 | 000 |
| 07630030807718 | K122911 | 000 |
| 07630030807060 | K122911 | 000 |
| 07630030807053 | K122911 | 000 |
| 07630030807046 | K122911 | 000 |
| 07630030807039 | K122911 | 000 |
| 07630030806766 | K122911 | 000 |
| 07630030806759 | K122911 | 000 |
| 07630030806742 | K122911 | 000 |
| 07630030807732 | K122911 | 000 |
| 07630030807855 | K122911 | 000 |
| 07630030807947 | K122911 | 000 |
| 07630030807930 | K122911 | 000 |
| 07630030807923 | K122911 | 000 |
| 07630030807916 | K122911 | 000 |
| 07630030807909 | K122911 | 000 |
| 07630030807893 | K122911 | 000 |
| 07630030807886 | K122911 | 000 |
| 07630030807879 | K122911 | 000 |
| 07630030807862 | K122911 | 000 |
| 07630030806735 | K122911 | 000 |