Endoskeleton TCS System
FDA 510(k) clearance K142940 · decided 2015-01-28
Clearance details
- K-number
- K142940
- Device name
- Endoskeleton TCS System
- Applicant
- Titan Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-10-09
- Decision date
- 2015-01-28
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mequon, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TC recall (Z-2327-2015) | TITAN SPINE, LLC | 2015-08-03 |
| Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spi recall (Z-1324-2015) | TITAN SPINE, LLC | 2015-03-26 |