The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Versafit Cup Double Mobility System.
| Device ID | K083116 |
| 510k Number | K083116 |
| Device Name: | VERSAFIT CUP DOUBLE MOBILITY SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-21 |
| Decision Date | 2009-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030808296 | K083116 | 000 |
| 07630030807336 | K083116 | 000 |
| 07630030807275 | K083116 | 000 |
| 07630030807237 | K083116 | 000 |
| 07630030807015 | K083116 | 000 |
| 07630030806995 | K083116 | 000 |
| 07630030806971 | K083116 | 000 |
| 07630030806957 | K083116 | 000 |
| 07630030806933 | K083116 | 000 |
| 07630030806919 | K083116 | 000 |
| 07630030806896 | K083116 | 000 |
| 07630030806872 | K083116 | 000 |
| 07630030806858 | K083116 | 000 |
| 07630030807374 | K083116 | 000 |
| 07630030807404 | K083116 | 000 |
| 07630030807435 | K083116 | 000 |
| 07630030808265 | K083116 | 000 |
| 07630030808234 | K083116 | 000 |
| 07630030808203 | K083116 | 000 |
| 07630030808173 | K083116 | 000 |
| 07630030808128 | K083116 | 000 |
| 07630030808098 | K083116 | 000 |
| 07630030808067 | K083116 | 000 |
| 07630030808036 | K083116 | 000 |
| 07630030808012 | K083116 | 000 |
| 07630030807527 | K083116 | 000 |
| 07630030807497 | K083116 | 000 |
| 07630030807466 | K083116 | 000 |
| 07630030806827 | K083116 | 000 |