ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE— 510(k) K945087

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K945087 for ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE, Substantially Equivalent on 1995-03-17. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1994-10-17
Decision date: 1995-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.