LAGUNA PEDICLE SCREW SYSTEM
FDA 510(k) clearance K103748 · decided 2011-03-02
Clearance details
- K-number
- K103748
- Device name
- LAGUNA PEDICLE SCREW SYSTEM
- Applicant
- Phygen, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-12-23
- Decision date
- 2011-03-02
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.