TSRH SACRAL SPINAL SCREW— 510(k) K883783

Substantially Equivalent for Some Indications

Warsaw Orthopedic, Inc.

FDA 510(k) clearance K883783 for TSRH SACRAL SPINAL SCREW, Substantially Equivalent for Some Indications on 1989-04-06. Applicant: Warsaw Orthopedic, Inc..

Clearance details

Applicant: Warsaw Orthopedic, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1988-09-06
Decision date: 1989-04-06
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, 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.