The following data is part of a premarket notification filed by Zimmer Biomet Spine Inc. with the FDA for Biomet Fusion System.
| Device ID | K163543 |
| 510k Number | K163543 |
| Device Name: | Biomet Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Zimmer Biomet Spine Inc. 310 Interlocken Parkway Suite 120 Broomfield, CO 80021 |
| Contact | Megan Fessenden |
| Correspondent | Megan Fessenden Zimmer Biomet Spine Inc. 310 Interlocken Parkway Suite 120 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-02-28 |
| Summary: | summary |