Solstice CCI
FDA 510(k) clearance K200896 · decided 2020-04-28
Clearance details
- K-number
- K200896
- Device name
- Solstice CCI
- Applicant
- Life Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-03
- Decision date
- 2020-04-28
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- NKG
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Huntley, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.