The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Total Hip Prothesis System-amisten H , Quadra H, Quadra S.
| Device ID | K093944 |
| 510k Number | K093944 |
| Device Name: | MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL SUITE B Camarillo, CA 93012 |
| Contact | Heather Neely |
| Correspondent | Heather Neely MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL SUITE 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 | 2009-12-22 |
| Decision Date | 2010-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030804243 | K093944 | 000 |
| 07630030802645 | K093944 | 000 |
| 07630030802652 | K093944 | 000 |
| 07630030802669 | K093944 | 000 |
| 07630030802676 | K093944 | 000 |
| 07630030802683 | K093944 | 000 |
| 07630030802690 | K093944 | 000 |
| 07630030802706 | K093944 | 000 |
| 07630030802744 | K093944 | 000 |
| 07630030802591 | K093944 | 000 |
| 07630030802584 | K093944 | 000 |
| 07630030802379 | K093944 | 000 |
| 07630030802485 | K093944 | 000 |
| 07630030802492 | K093944 | 000 |
| 07630030802508 | K093944 | 000 |
| 07630030802515 | K093944 | 000 |
| 07630030802522 | K093944 | 000 |
| 07630030802560 | K093944 | 000 |
| 07630030802577 | K093944 | 000 |
| 07630030802751 | K093944 | 000 |
| 07630030802768 | K093944 | 000 |
| 07630030804151 | K093944 | 000 |
| 07630030804175 | K093944 | 000 |
| 07630030804182 | K093944 | 000 |
| 07630030804199 | K093944 | 000 |
| 07630030804205 | K093944 | 000 |
| 07630030804212 | K093944 | 000 |
| 07630030804229 | K093944 | 000 |
| 07630030804236 | K093944 | 000 |
| 07630030804144 | K093944 | 000 |
| 07630030804137 | K093944 | 000 |
| 07630030802775 | K093944 | 000 |
| 07630030804069 | K093944 | 000 |
| 07630030804076 | K093944 | 000 |
| 07630030804083 | K093944 | 000 |
| 07630030804090 | K093944 | 000 |
| 07630030804106 | K093944 | 000 |
| 07630030804113 | K093944 | 000 |
| 07630030804120 | K093944 | 000 |
| 07630030802294 | K093944 | 000 |