VERTEBRON PSS PEDICLE SCREW SYSTEM— 510(k) K051716

Substantially Equivalent

Vertebron, Inc.

FDA 510(k) clearance K051716 for VERTEBRON PSS PEDICLE SCREW SYSTEM, Substantially Equivalent on 2005-09-07. Applicant: Vertebron, Inc..

Clearance details

Applicant: Vertebron, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2005-06-27
Decision date: 2005-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Stratford, CT, 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.