The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Synergy(tm) Ti Posterior Spinal System.
| Device ID | K950099 |
| 510k Number | K950099 |
| Device Name: | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1997-01-16 |
| Summary: | summary |