Vitality Spinal Fixation System, Vitality+ Power Instrument System
510(k) K172275
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172275 | Date27 Sep 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Vitality Spinal Fixation System is a spinal fixation system comprising spinal rods, pedicle screws, hooks, and connectors for temporary stabilization during spinal fusion. It is intended for use in spinal fusion procedures to provide stabilization of the vertebral column.
The system includes the Vitality+ Power Instrument System, which consists of drills, taps, drivers, and adapters designed for use with the Zimmer Biomet Universal Power System to facilitate pedicle and ilium preparation and screw insertion using a power surgical technique. Implants are constructed from medical grade titanium alloy or cobalt chromium and are supplied sterile for single-use only. The device is used in the operating room by surgeons for open or minimally invasive spinal procedures and has received FDA 510(k) clearance under product code NKB.
Other devices from Zimmer Biomet Spine, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Vitality Spinal Fixation System used for?
The Vitality Spinal Fixation System is intended for temporary stabilization of the vertebral column during spinal fusion procedures, providing support through spinal rods, pedicle screws, hooks, and connectors in both open and minimally invasive approaches.
Is the Vitality Spinal Fixation System supplied sterile and for single-use only?
Yes, all implants in the Vitality Spinal Fixation System are constructed from medical grade titanium alloy or cobalt chromium and are supplied sterile for single-use only, ensuring patient safety and eliminating risks associated with reprocessing.
What components are included in the Vitality+ Power Instrument System?
The Vitality+ Power Instrument System includes drills, taps, drivers, and adapters designed to work with the Zimmer Biomet Universal Power System to facilitate pedicle and ilium preparation and screw insertion using a powered surgical technique.