INTERPLATE C— 510(k) K092070

Substantially Equivalent

Rsb Spine, LLC

FDA 510(k) clearance K092070 for INTERPLATE C, Substantially Equivalent on 2009-10-06. Applicant: Rsb Spine, LLC.

Clearance details

Applicant
Rsb Spine, LLC
Product code
Code KWQ
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 KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

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.