Renovis Surgical Hip Replacement System— 510(k) K171543
Substantially EquivalentRenovis Surgical Technologies
FDA 510(k) clearance K171543 for Renovis Surgical Hip Replacement System, Substantially Equivalent on 2017-11-16. Applicant: Renovis Surgical Technologies. Device class: 2.
Clearance details
- Applicant
- Renovis Surgical Technologies
- Product code
- Code OQG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redlands, CA, US
Recent devices under product code OQG
view all- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
- K203472 — KMTI Hip Replacement System
- K201660 — KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K172651 — FMP Extended Liners
More clearances from Renovis Surgical Technologies
view all- K190122 — Renovis A200 PS Knee System as part of the Renovis A200 Knee System
- K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
- K181655 — Renovis S180 Lateral Lumbar Interbody Fusion System
- K170888 — Renovis S141 Lumbar Interbody Fusion System
- K153250 — Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Adverse events under product code OQG
product code OQG- Injury
- 249
- Total
- 249
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.