CHESAPEAKE SPINAL SYSTEM— 510(k) K133494

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K133494 for CHESAPEAKE SPINAL SYSTEM, Substantially Equivalent on 2014-06-10. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2013-11-14
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.