PressON Spinal Fixation System
FDA 510(k) clearance K253331 · decided 2025-10-14
Clearance details
- K-number
- K253331
- Device name
- PressON Spinal Fixation System
- Applicant
- Nexus Spine
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2025-10-14
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.