PROPOSED OPTIMUS— 510(k) K132596

Substantially Equivalent

Custom Spine, Inc.

FDA 510(k) clearance K132596 for PROPOSED OPTIMUS, Substantially Equivalent on 2014-04-11. Applicant: Custom Spine, Inc..

Clearance details

Applicant: Custom Spine, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2013-08-19
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, 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.