FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
K Number: K153250
·
Decision Mar 16, 2016
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
7
Review Days
128
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Basic Information
- Device Name
- Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
- K Number
- K153250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovis Surgical Technologies
- Date Received
- November 9, 2015
- Decision Date
- March 16, 2016
- 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 Renovis Surgical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Jun 20, 2019 | Substantially Equivalent |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Dec 7, 2018 | Substantially Equivalent |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Sep 11, 2018 | Substantially Equivalent |
| K171543 | Renovis Surgical Hip Replacement System | Nov 16, 2017 | Substantially Equivalent |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | Aug 8, 2017 | Substantially Equivalent |
| K143126 | Renovis S141 Lumbar Interbody Cage System | Feb 6, 2015 | Substantially Equivalent |