EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
FDA 510(k) clearance K181603 · decided 2018-10-05
Clearance details
- K-number
- K181603
- Device name
- EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
- Applicant
- K2m, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-19
- Decision date
- 2018-10-05
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- NKG
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leesburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.