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 | K010681 |
| 510k Number | K010681 |
| Device Name: | SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Maas |
| Correspondent | Frank Maas DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-07 |
| Decision Date | 2001-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034022857 | K010681 | 000 |