TILOCK PEDICLE SCREW SYSTEM
FDA 510(k) clearance K100757 · decided 2010-07-01
Clearance details
- K-number
- K100757
- Device name
- TILOCK PEDICLE SCREW SYSTEM
- Applicant
- Genesys Spine
- Decision
- Substantially Equivalent
- Date received
- 2010-03-17
- Decision date
- 2010-07-01
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Sp recall (Z-2677-2014) | Genesys Orthopedics Systems, LLC | 2014-09-22 |