The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Pedicle Screw System.
Device ID | K211027 |
510k Number | K211027 |
Device Name: | Altus Spine Pedicle Screw System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Contact | Mark Melton |
Correspondent | Rand Baker Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-06 |
Decision Date | 2022-09-16 |