X-spine Pedicle Screw System
FDA 510(k) clearance K152132 · decided 2015-09-25
Clearance details
- K-number
- K152132
- Device name
- X-spine Pedicle Screw System
- Applicant
- X-Spine Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-31
- Decision date
- 2015-09-25
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MNI
- Device class
- 2
- Regulation number
- 888.3070
- 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 |
|---|---|---|
| XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. recall (Z-1773-2026) | XTANT Medical Holdings, Inc | 2026-04-03 |