The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Falcon Spacer.
| Device ID | K123180 |
| 510k Number | K123180 |
| Device Name: | FALCON SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Monika Mcdole-russell |
| Correspondent | Monika Mcdole-russell SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST 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 | 2012-10-10 |
| Decision Date | 2013-01-08 |
| Summary: | summary |