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 |