The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Syncage Evolution Spacer.
| Device ID | K122639 |
| 510k Number | K122639 |
| Device Name: | SYNTHES SYNCAGE EVOLUTION SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1230 Wilson Dr West Chester, PA 19380 |
| Contact | Hemal Mehta |
| Correspondent | Hemal Mehta SYNTHES (USA) PRODUCTS LLC 1230 Wilson Dr West Chester, PA 19380 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2013-05-24 |
| Summary: | summary |