LANCER PEDICLE SCREW SYSTEM
FDA 510(k) clearance K110633 · decided 2011-12-15
Clearance details
- K-number
- K110633
- Device name
- LANCER PEDICLE SCREW SYSTEM
- Applicant
- Spinal Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-03-04
- Decision date
- 2011-12-15
- Days to decision
- 286 days
- Clearance type
- Special
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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