Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
FDA 510(k) clearance K192018 · decided 2019-08-16
Clearance details
- K-number
- K192018
- Device name
- Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device
- Applicant
- Titan Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-29
- Decision date
- 2019-08-16
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- ODP
- 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
No recalls on record reference this clearance.