The following data is part of a premarket notification filed by Apollo Spine, Inc. with the FDA for Zenith Pedicle System.
| Device ID | K102636 |
| 510k Number | K102636 |
| Device Name: | ZENITH PEDICLE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-13 |
| Decision Date | 2011-03-03 |
| Summary: | summary |