The following data is part of a premarket notification filed by Medacta International with the FDA for Amistem And Quadra - Line Extension.
| Device ID | K121011 |
| 510k Number | K121011 |
| Device Name: | AMISTEM AND QUADRA - LINE EXTENSION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit 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 | 2012-04-03 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030804731 | K121011 | 000 |
| 07630030804601 | K121011 | 000 |
| 07630030804595 | K121011 | 000 |
| 07630030804588 | K121011 | 000 |
| 07630030804571 | K121011 | 000 |
| 07630030804564 | K121011 | 000 |
| 07630030804557 | K121011 | 000 |
| 07630030804540 | K121011 | 000 |
| 07630030804168 | K121011 | 000 |
| 07630030803765 | K121011 | 000 |
| 07630030802942 | K121011 | 000 |
| 07630030804618 | K121011 | 000 |
| 07630030804625 | K121011 | 000 |
| 07630030804724 | K121011 | 000 |
| 07630030804717 | K121011 | 000 |
| 07630030804700 | K121011 | 000 |
| 07630030804694 | K121011 | 000 |
| 07630030804687 | K121011 | 000 |
| 07630030804670 | K121011 | 000 |
| 07630030804663 | K121011 | 000 |
| 07630030804656 | K121011 | 000 |
| 07630030804649 | K121011 | 000 |
| 07630030804632 | K121011 | 000 |
| 07630030802935 | K121011 | 000 |