REPIPHYSIS LIMB SALVAGE SYSTEM— 510(k) K021489

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K021489 for REPIPHYSIS LIMB SALVAGE SYSTEM, Substantially Equivalent on 2002-12-04. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 2002-05-08
Decision date: 2002-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.