Swedge™ Pedicle Screw Fixation System Bezier Rod
FDA 510(k) clearance K252461 · decided 2026-01-13
Clearance details
- K-number
- K252461
- Device name
- Swedge™ Pedicle Screw Fixation System Bezier Rod
- Applicant
- Spinal Resources, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-05
- Decision date
- 2026-01-13
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.