The following data is part of a premarket notification filed by Biomet Spine with the FDA for Biomet Fusion System.
| Device ID | K141791 |
| 510k Number | K141791 |
| Device Name: | BIOMET FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | BIOMET SPINE 310 INTERLOCKEN PARKWAY Broomfield, CO 80021 |
| Contact | Ted Kuhn |
| Correspondent | Ted Kuhn BIOMET SPINE 310 INTERLOCKEN PARKWAY Broomfield, CO 80021 |
| Product Code | OVD |
| Subsequent Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-10-09 |
| Summary: | summary |