Cleared Traditional

Calibrate Interbody Systems

K243461 · Alphatec Spine, Inc. · Orthopedic

Mar 2025

Decision

116d

Days

—

Risk

About This 510(k) Submission

K243461 is an FDA 510(k) clearance for the Calibrate Interbody Systems, submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 4, 2025, 116 days after receiving the submission on November 8, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number	K243461 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2024
Decision Date	March 04, 2025
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF