The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for Vitality® Spinal Fixation System.
Device ID | K203507 |
510k Number | K203507 |
Device Name: | Vitality® Spinal Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
Contact | Alex Pawlowski |
Correspondent | Alex Pawlowski Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-11-30 |
Decision Date | 2021-01-28 |