The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine™ Ps.
Device ID | K201648 |
510k Number | K201648 |
Device Name: | Sterispine™ PS |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Safe Orthopaedics Parc Des Bellevues, Allee R. Luxembourg-Bat. Californie Eragny Sur Oise, FR 95610 |
Contact | Pierre Dumouchel |
Correspondent | Pierre Dumouchel Safe Orthopaedics Parc Des Bellevues, Le Californie - Allee Rosa Luxemburg Eragny Sur Oise, FR 95610 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-06-18 |
Decision Date | 2020-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STERISPINE 90720535 not registered Live/Pending |
SAFE ORTHOPAEDICS 2021-05-19 |
STERISPINE 85356563 4196928 Dead/Cancelled |
SAFE ORTHOPAEDICS 2011-06-27 |