SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220— 510(k) K993808

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K993808 for SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220, Substantially Equivalent on 1999-12-06. Applicant: Interpore Cross Intl..

Clearance details

Applicant
Interpore Cross Intl.
Product code
Code MNH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MNH

product code MNH
Injury
978
Malfunction
793
Total
1,771

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.