The following data is part of a premarket notification filed by Novastep with the FDA for Airlock Osteosynthesis Plate System.
Device ID | K143523 |
510k Number | K143523 |
Device Name: | Airlock Osteosynthesis Plate System |
Classification | Plate, Fixation, Bone |
Applicant | NOVASTEP Eapace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769 |
Contact | Gilles Audic |
Correspondent | Gilles Audic NOVASTEP Eapace Performance Alphasis - Batiment C1-C2 Saint Gregoire, FR 35769 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-12 |
Decision Date | 2015-04-06 |
Summary: | summary |