FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Endoskeleton(r) TCS System
K Number: K153122
·
Decision Dec 14, 2015
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
14
Review Days
46
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Basic Information
- Device Name
- Endoskeleton(r) TCS System
- K Number
- K153122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Titan Spine, LLC
- Date Received
- October 29, 2015
- Decision Date
- December 14, 2015
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Titan Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | Feb 13, 2018 | Substantially Equivalent |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | Jul 6, 2017 | Substantially Equivalent |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | Apr 13, 2017 | Substantially Equivalent |
| K151596 | Endoskeleton TCS Interbody Fusion Device | Oct 9, 2015 | Substantially Equivalent |
| K142940 | Endoskeleton TCS System | Jan 28, 2015 | Substantially Equivalent |
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | Oct 27, 2014 | Substantially Equivalent |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | Oct 17, 2014 | Substantially Equivalent |
| K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | Jul 2, 2014 | Substantially Equivalent |
| K111626 | ENDOSKELETON(R) TAS | Sep 9, 2011 | Substantially Equivalent |
| K102067 | ENDOSKELETON TO | Nov 5, 2010 | Substantially Equivalent |