LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
FDA 510(k) clearance K113366 · decided 2012-01-17
Clearance details
- K-number
- K113366
- Device name
- LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
- Applicant
- Phygen, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-11-15
- Decision date
- 2012-01-17
- Days to decision
- 63 days
- Clearance type
- Special
- 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
| Record | Firm | Date |
|---|---|---|
| Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, imm recall (Z-1421-2013) | Alphatec Spine, Inc. | 2013-05-28 |