TSRH OPEN HEAD BONE SCREW— 510(k) K911319

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K911319 for TSRH OPEN HEAD BONE SCREW, Substantially Equivalent on 1991-09-06. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1991-03-26
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.