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 | K170553 |
510k Number | K170553 |
Device Name: | Altus Spine Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-24 |
Decision Date | 2017-12-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00843210130927 | K170553 | 000 |
00843210130484 | K170553 | 000 |
00843210130460 | K170553 | 000 |
00843210130446 | K170553 | 000 |
00843210130422 | K170553 | 000 |
00843210130408 | K170553 | 000 |
00843210130385 | K170553 | 000 |
00843210130361 | K170553 | 000 |
00843210130347 | K170553 | 000 |
00843210130330 | K170553 | 000 |
00843210130323 | K170553 | 000 |
00843210130507 | K170553 | 000 |
00843210130521 | K170553 | 000 |
00843210130545 | K170553 | 000 |
00843210130873 | K170553 | 000 |
00843210130828 | K170553 | 000 |
00843210130774 | K170553 | 000 |
00843210130729 | K170553 | 000 |
00843210130675 | K170553 | 000 |
00843210130651 | K170553 | 000 |
00843210130606 | K170553 | 000 |
00843210130583 | K170553 | 000 |
00843210130576 | K170553 | 000 |
00843210130569 | K170553 | 000 |
00843210130316 | K170553 | 000 |