FDA applicant
Renovis Surgical Technologies, LLC
FDA records 23 decisions for Renovis Surgical Technologies, LLC (Redlands, CA) from 2010 to 2019: 23 510(k) clearances. Most are in product codes OVD (Intervertebral Fusion Device With Integrated…) and OQG (Hip Prosthesis, Semi-Constrained, Cemented…). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 75 predicates, 18 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Renovis Surgical Technologies”, “Renovis Surgical Technologies, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Renovis Surgical Technologies, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Renovis Surgical Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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