Cleared Traditional

K243461 - Calibrate Interbody Systems (FDA 510(k) Clearance)

K243461 · Alphatec Spine, Inc. · Orthopedic device
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Mar 2025
Decision
116d
Days
-
Risk

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 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K243461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -