FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K192018
·
Decision Aug 16, 2019
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
5
Review Days
18
Basic Information
- 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
- K Number
- K192018
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Titan Spine, Inc.
- Date Received
- July 29, 2019
- Decision Date
- August 16, 2019
- Product Code
- ODP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Titan Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | Jan 8, 2020 | Substantially Equivalent |
| K192054 | Endoskeleton TAS Plate | Aug 29, 2019 | Substantially Equivalent |
| K191565 | Endoskeleton TCS Interbody Fusion Device | Aug 6, 2019 | Substantially Equivalent |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS 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, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | Feb 11, 2019 | Substantially Equivalent |