AXIAL COMPRESSION SCREW— 510(k) K870786

Name: FDA 510(k) clearance K870786
Creator: U.S. Food and Drug Administration
Published: 1987-06-01

Substantially Equivalent

Straub Clinic and Hospital

FDA 510(k) clearance K870786 for AXIAL COMPRESSION SCREW, Substantially Equivalent on 1987-06-01. Applicant: Straub Clinic and Hospital. Device class: 2.

Clearance details

Applicant: Straub Clinic and Hospital
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1987-02-26
Decision date: 1987-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honolulu, HI, 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.