The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Cervical Interbody Fusion System.
Device ID | K172253 |
510k Number | K172253 |
Device Name: | Altus Spine Cervical Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Contact | Mark Melton |
Correspondent | Mark Melton Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-26 |
Decision Date | 2017-11-21 |
Summary: | summary |