The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short Neck.
| Device ID | K103189 |
| 510k Number | K103189 |
| Device Name: | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2010-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030804335 | K103189 | 000 |
| 07630030802928 | K103189 | 000 |
| 07630030802911 | K103189 | 000 |
| 07630030802904 | K103189 | 000 |
| 07630030802898 | K103189 | 000 |
| 07630030802881 | K103189 | 000 |
| 07630030802874 | K103189 | 000 |
| 07630030802867 | K103189 | 000 |
| 07630030802850 | K103189 | 000 |
| 07630030802843 | K103189 | 000 |
| 07630030802836 | K103189 | 000 |
| 07630030802829 | K103189 | 000 |
| 07630030802812 | K103189 | 000 |
| 07630030802805 | K103189 | 000 |
| 07630030802799 | K103189 | 000 |
| 07630030803789 | K103189 | 000 |
| 07630030803796 | K103189 | 000 |
| 07630030803802 | K103189 | 000 |
| 07630030804328 | K103189 | 000 |
| 07630030804311 | K103189 | 000 |
| 07630030804304 | K103189 | 000 |
| 07630030804298 | K103189 | 000 |
| 07630030804281 | K103189 | 000 |
| 07630030804274 | K103189 | 000 |
| 07630030804267 | K103189 | 000 |
| 07630030804250 | K103189 | 000 |
| 07630030803864 | K103189 | 000 |
| 07630030803857 | K103189 | 000 |
| 07630030803840 | K103189 | 000 |
| 07630030803833 | K103189 | 000 |
| 07630030803826 | K103189 | 000 |
| 07630030803819 | K103189 | 000 |
| 07630030802782 | K103189 | 000 |