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 |