THEKEN REVEAL VBR SYSTEM— 510(k) K050058

Substantially Equivalent

Theken Surgical,Llc

FDA 510(k) clearance K050058 for THEKEN REVEAL VBR SYSTEM, Substantially Equivalent on 2005-05-17. Applicant: Theken Surgical,Llc.

Clearance details

Applicant: Theken Surgical,Llc
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2005-01-11
Decision date: 2005-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.