The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synfix-lr.
| Device ID | K053508 |
| 510k Number | K053508 |
| Device Name: | SYNFIX-LR |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Angela Mikroulis |
| Correspondent | Angela Mikroulis SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-02-13 |
| Summary: | summary |