CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE— 510(k) K091134

Substantially Equivalent

Custom Spine, Inc.

FDA 510(k) clearance K091134 for CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE, Substantially Equivalent on 2009-08-17. Applicant: Custom Spine, Inc..

Clearance details

Applicant: Custom Spine, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2009-04-20
Decision date: 2009-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.