INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC— 510(k) K071922

Name: FDA 510(k) clearance K071922
Creator: U.S. Food and Drug Administration
Published: 2007-09-18

Substantially Equivalent

Rsb Spine, LLC

FDA 510(k) clearance K071922 for INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC, Substantially Equivalent on 2007-09-18. Applicant: Rsb Spine, LLC. Device class: 2.

Clearance details

Applicant: Rsb Spine, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2007-07-12
Decision date: 2007-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

Download summary PDF View on FDA.gov ↗

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K081194 — INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)2008-05-29
K071372 — MODIFICATION TO: INTERPLATE VBR SYSTEM2007-06-11
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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.