The following data is part of a premarket notification filed by Biomet Spine, Llc. with the FDA for Biomet Spine Fusion System.
| Device ID | K142634 |
| 510k Number | K142634 |
| Device Name: | Biomet Spine Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BIOMET SPINE, LLC. 310 Interlocken Pkwy Ste 120 Broomfield, CO 80021 |
| Contact | Mike Medina |
| Correspondent | Mike Medina BIOMET SPINE, LLC. 310 Interlocken Pkwy Ste 120 Broomfield, CO 80021 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-03-12 |
| Summary: | summary |