The following data is part of a premarket notification filed by In2bones Sas with the FDA for Stabilization Screw.
Device ID | K131920 |
510k Number | K131920 |
Device Name: | STABILIZATION SCREW |
Classification | Screw, Fixation, Bone |
Applicant | IN2BONES SAS 9109 COPENHAVER DR. Potomac, MD 20854 |
Contact | Norman F Estrin, Ph.d. |
Correspondent | Norman F Estrin, Ph.d. IN2BONES SAS 9109 COPENHAVER DR. Potomac, MD 20854 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-26 |
Decision Date | 2014-05-01 |
Summary: | summary |