NEO Pedicle Screw System™
FDA 510(k) clearance K171582 · decided 2017-09-12
Clearance details
- K-number
- K171582
- Device name
- NEO Pedicle Screw System™
- Applicant
- Neo Medical SA
- Decision
- Substantially Equivalent
- Date received
- 2017-05-31
- Decision date
- 2017-09-12
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Villette (Lavaux), CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.