Vitality® Spinal Fixation System
FDA 510(k) clearance K171907 · decided 2017-07-14
Clearance details
- K-number
- K171907
- Device name
- Vitality® Spinal Fixation System
- Applicant
- Zimmer Biomet Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-26
- Decision date
- 2017-07-14
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Westminister, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pe recall (Z-0866-2019) | Zimmer Biomet Spine Inc. | 2019-02-22 |
| Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). recall (Z-0867-2019) | Zimmer Biomet Spine Inc. | 2019-02-22 |