IRIX-A Lumbar Integrated Fusion System
FDA 510(k) clearance K171567 · decided 2017-08-28
Clearance details
- K-number
- K171567
- Device name
- IRIX-A Lumbar Integrated Fusion System
- Applicant
- X-Spine Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-30
- Decision date
- 2017-08-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miamisburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 3 recall (Z-1177-2025) | XTANT Medical Holdings, Inc | 2025-02-19 |