The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Oc Fusion System.
| Device ID | K053418 |
| 510k Number | K053418 |
| Device Name: | SYNTHES OC FUSION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-09-06 |
| Summary: | summary |