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

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.

Clearance details

Applicant
Rsb Spine, LLC
Product code
Code OVD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chesterland, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

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.