Lucent®
FDA 510(k) clearance K170235 · decided 2017-11-29
Clearance details
- K-number
- K170235
- Device name
- Lucent®
- Applicant
- Spinal Elements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-25
- Decision date
- 2017-11-29
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.