The following data is part of a premarket notification filed by Apollo Spine, Inc. with the FDA for Venus Facet Screw System.
Device ID | K120340 |
510k Number | K120340 |
Device Name: | VENUS FACET SCREW SYSTEM |
Classification | System, Facet Screw Spinal Device |
Applicant | APOLLO SPINE, INC. 75 MILL STREET Stoughton, MA 02072 |
Contact | Christine Santagate |
Correspondent | Christine Santagate APOLLO SPINE, INC. 75 MILL STREET Stoughton, MA 02072 |
Product Code | MRW |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-03 |
Decision Date | 2012-10-19 |
Summary: | summary |