The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Titanium Interbody Fusion System.
Device ID | K171329 |
510k Number | K171329 |
Device Name: | Altus Spine Titanium Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Contact | Claudia Hill |
Correspondent | Mark Melton Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-05 |
Decision Date | 2017-08-29 |
Summary: | summary |