DEPUY COMPRESSION HIP SCREW SYSTEM— 510(k) K861178

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K861178 for DEPUY COMPRESSION HIP SCREW SYSTEM, Substantially Equivalent on 1986-04-15. Applicant: Depuy, Inc..

Clearance details

Applicant
Depuy, Inc.
Product code
Code KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.