The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Summit Oct Spinal System Minipolyaxial Screws.
| Device ID | K030103 |
| 510k Number | K030103 |
| Device Name: | SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Mass |
| Correspondent | Frank Mass DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-13 |
| Decision Date | 2003-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034022352 | K030103 | 000 |
| 10705034021591 | K030103 | 000 |
| 10705034021607 | K030103 | 000 |
| 10705034021621 | K030103 | 000 |
| 10705034021638 | K030103 | 000 |
| 10705034021706 | K030103 | 000 |
| 10705034021713 | K030103 | 000 |
| 10705034021911 | K030103 | 000 |
| 10705034021928 | K030103 | 000 |
| 10705034021942 | K030103 | 000 |
| 10705034022031 | K030103 | 000 |
| 10705034021508 | K030103 | 000 |