The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Cc.
| Device ID | K162531 |
| 510k Number | K162531 |
| Device Name: | STERISPINE CC |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SAFE ORTHOPAEDICS PARC DES BELLEVUES ALLEE R. LUXEMBURG - BAT. CALIFORNIE Eragny Sur Oise, FR 95610 |
| Contact | Sophie Rehault |
| Correspondent | Sophie Rehault SAFE ORTHOPAEDICS PARC DES BELLEVUES ALLEE R. LUXEMBURG - BAT. CALIFORNIE Eragny Sur Oise, FR 95610 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2016-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760219913153 | K162531 | 000 |
| 03760219913061 | K162531 | 000 |
| 03760219913078 | K162531 | 000 |
| 03760219913085 | K162531 | 000 |
| 03760219913092 | K162531 | 000 |
| 03760219913108 | K162531 | 000 |
| 03760219913115 | K162531 | 000 |
| 03760219913122 | K162531 | 000 |
| 03760219913139 | K162531 | 000 |
| 03760219913146 | K162531 | 000 |
| 03760219913054 | K162531 | 000 |