The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Summit Occipito-cervico- Thoracic (oct) Spinal System.
| Device ID | K013222 |
| 510k Number | K013222 |
| Device Name: | SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Karen F Jurczak |
| Correspondent | Karen F Jurczak DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-27 |
| Decision Date | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034022901 | K013222 | 000 |