BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM— 510(k) K102449

Substantially Equivalent

Bright Spine, Inc.

FDA 510(k) clearance K102449 for BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM, Substantially Equivalent on 2011-02-11. Applicant: Bright Spine, Inc..

Clearance details

Applicant: Bright Spine, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2010-08-27
Decision date: 2011-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.