SOLAS ANATOMIX SPINAL SYSTEM— 510(k) K083178

Substantially Equivalent

Biotechni America Spine Group, Inc.

FDA 510(k) clearance K083178 for SOLAS ANATOMIX SPINAL SYSTEM, Substantially Equivalent on 2009-02-23. Applicant: Biotechni America Spine Group, Inc..

Clearance details

Applicant: Biotechni America Spine Group, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2008-10-28
Decision date: 2009-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.