FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Renovis A200 PS Knee System as part of the Renovis A200 Knee System
K Number: K190122
·
Decision Jun 20, 2019
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
7
Review Days
146
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Renovis A200 PS Knee System as part of the Renovis A200 Knee System
- K Number
- K190122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Renovis Surgical Technologies
- Date Received
- January 25, 2019
- Decision Date
- June 20, 2019
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Renovis Surgical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | Mar 16, 2016 | Substantially Equivalent |
| K143126 | Renovis S141 Lumbar Interbody Cage System | Feb 6, 2015 | Substantially Equivalent |