The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Oc Fusion And Synapse Systems.
| Device ID | K072434 |
| 510k Number | K072434 |
| Device Name: | SYNTHES OC FUSION AND SYNAPSE SYSTEMS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-29 |
| Decision Date | 2008-01-10 |
| Summary: | summary |