ACE/KYLE CAPTURED HIP SCREW— 510(k) K813554

Name: FDA 510(k) clearance K813554
Creator: U.S. Food and Drug Administration
Published: 1982-01-12

Substantially Equivalent

Ace Orthopedic Manufacturing Co.

FDA 510(k) clearance K813554 for ACE/KYLE CAPTURED HIP SCREW, Substantially Equivalent on 1982-01-12. Applicant: Ace Orthopedic Manufacturing Co.. Device class: 2.

Clearance details

Applicant: Ace Orthopedic Manufacturing Co.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1981-12-22
Decision date: 1982-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ace Orthopedic Manufacturing Co.

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K934643 — ACE HUMERAL NAIL1994-03-22
K934962 — AIM SUPRACONDYLAR NAIL1994-03-22
K936045 — ACE UNILATERAL FIXATOR II1994-02-22
K926047 — ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW1993-03-31
K920738 — ACE 100 DEGREES TUBULAR PLATE1992-07-27

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.