Renovis A200 PS Knee System as part of the Renovis A200 Knee System— 510(k) K190122
Substantially EquivalentRenovis Surgical Technologies
FDA 510(k) clearance K190122 for Renovis A200 PS Knee System as part of the Renovis A200 Knee System, Substantially Equivalent on 2019-06-20. Applicant: Renovis Surgical Technologies. Device class: 2.
Clearance details
- Applicant
- Renovis Surgical Technologies
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redlands, CA, US
Recent devices under product code JWH
view allMore clearances from Renovis Surgical Technologies
view all- K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System
- K171543 — Renovis Surgical Hip Replacement System
- K170888 — Renovis S141 Lumbar Interbody Fusion System
- K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.