The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners.
| Device ID | K092265 |
| 510k Number | K092265 |
| Device Name: | VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS |
| 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 Kennel |
| Correspondent | Natalie 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 | 2009-07-29 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030807534 | K092265 | 000 |
| 07630030806865 | K092265 | 000 |
| 07630030806889 | K092265 | 000 |
| 07630030806902 | K092265 | 000 |
| 07630030806926 | K092265 | 000 |
| 07630030806940 | K092265 | 000 |
| 07630030806964 | K092265 | 000 |
| 07630030806988 | K092265 | 000 |
| 07630030807008 | K092265 | 000 |
| 07630030807022 | K092265 | 000 |
| 07630030807244 | K092265 | 000 |
| 07630030807282 | K092265 | 000 |
| 07630030807343 | K092265 | 000 |
| 07630030807381 | K092265 | 000 |
| 07630030807411 | K092265 | 000 |
| 07630030807442 | K092265 | 000 |
| 07630030807473 | K092265 | 000 |
| 07630030807503 | K092265 | 000 |
| 07630030806834 | K092265 | 000 |