DEPUY AE TK2 HIP SCREW SYSTEM— 510(k) K972629

Name: FDA 510(k) clearance K972629
Creator: U.S. Food and Drug Administration
Published: 1997-10-09

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K972629 for DEPUY AE TK2 HIP SCREW SYSTEM, Substantially Equivalent on 1997-10-09. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1997-07-14
Decision date: 1997-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.