RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM— 510(k) K142095

Name: FDA 510(k) clearance K142095
Creator: U.S. Food and Drug Administration
Published: 2014-10-15

Substantially Equivalent

Renovis Surgical Technologies, Inc.

FDA 510(k) clearance K142095 for RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM, Substantially Equivalent on 2014-10-15. Applicant: Renovis Surgical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Renovis Surgical Technologies, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2014-08-01
Decision date: 2014-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashland, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
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K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10

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K143647 — Renovis Surgical Hip Replacement System2015-05-11
K141676 — RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM2014-11-04
K141370 — RENOVIS CEMENTED HIP SYSTEM2014-09-02

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.