The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Interbody Fusion System.
| Device ID | K160976 |
| 510k Number | K160976 |
| Device Name: | Altus Spine Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ALTUS PARTNERS, LLC 5149 WEST CHESTER PIKE Newtown Square, PA 19073 |
| Contact | Claudia Hill |
| Correspondent | Claudia Hill ALTUS PARTNERS, LLC 5149 WEST CHESTER PIKE Newtown Square, PA 19073 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-07 |
| Decision Date | 2017-01-25 |
| Summary: | summary |