Edge Upper Cervical System
FDA 510(k) clearance K221307 · decided 2023-07-10
Clearance details
- K-number
- K221307
- Device name
- Edge Upper Cervical System
- Applicant
- Spinal Simplicity, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-05-05
- Decision date
- 2023-07-10
- Days to decision
- 431 days
- Clearance type
- Traditional
- Product code
- NKG
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Overland Park, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.