The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispineps Pedicle Screw.
Device ID | K112453 |
510k Number | K112453 |
Device Name: | STERISPINEPS PEDICLE SCREW |
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- ALLEE R LUXEMBOURG-BAT CALIFORNIE Eragny Sur Oise, FR 95610 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-25 |
Decision Date | 2011-11-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03760219910022 | K112453 | 000 |
03760219910046 | K112453 | 000 |
03760219910053 | K112453 | 000 |
03760219910060 | K112453 | 000 |
03760219910077 | K112453 | 000 |
03760219910084 | K112453 | 000 |
03760219910091 | K112453 | 000 |
03760219910107 | K112453 | 000 |
03760219910114 | K112453 | 000 |
03760219910121 | K112453 | 000 |
03760219910138 | K112453 | 000 |
03760219910145 | K112453 | 000 |
03760219910152 | K112453 | 000 |
03760219910169 | K112453 | 000 |
03760219910176 | K112453 | 000 |
03760219910183 | K112453 | 000 |
03760219910039 | K112453 | 000 |