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 |