TSRH VARIABLE ANGLE SACRAL SCREW— 510(k) K904243

Substantially Equivalent for Some Indications

Danek Medical, Inc.

FDA 510(k) clearance K904243 for TSRH VARIABLE ANGLE SACRAL SCREW, Substantially Equivalent for Some Indications on 1992-01-22. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1990-09-14
Decision date: 1992-01-22
Decision: Substantially Equivalent for Some Indications
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.