The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Optima Zs Transition Screw, Models Sda7030, 7055, Sd4030-8055.
| Device ID | K071880 |
| 510k Number | K071880 |
| Device Name: | OPTIMA ZS TRANSITION SCREW, MODELS SDA7030, 7055, SD4030-8055 |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55441 |
| Contact | Nicole Bowden |
| Correspondent | Nicole Bowden ZIMMER SPINE, INC 7375 BUSH LAKE RD. Minneapolis, MN 55441 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-10-05 |
| Summary: | summary |