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 | K002733 |
| 510k Number | K002733 |
| 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 Mass |
| Correspondent | Frank Mass 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 | 2000-09-01 |
| Decision Date | 2000-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034022789 | K002733 | 000 |
| 10705034021089 | K002733 | 000 |
| 10705034021096 | K002733 | 000 |
| 10705034021102 | K002733 | 000 |
| 10705034021119 | K002733 | 000 |
| 10705034022673 | K002733 | 000 |
| 10705034022703 | K002733 | 000 |
| 10705034022710 | K002733 | 000 |
| 10705034022727 | K002733 | 000 |
| 10705034022758 | K002733 | 000 |
| 10705034022765 | K002733 | 000 |
| 10705034022772 | K002733 | 000 |
| 10705034021072 | K002733 | 000 |