The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Line Extension.
| Device ID | K080885 |
| 510k Number | K080885 |
| Device Name: | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030805486 | K080885 | 000 |
| 07630030805479 | K080885 | 000 |
| 07630030805240 | K080885 | 000 |
| 07630030805233 | K080885 | 000 |
| 07630030805226 | K080885 | 000 |
| 07630030805219 | K080885 | 000 |
| 07630030805202 | K080885 | 000 |