Cleared Traditional

IntraOp Alignment System (K253216) - FDA 510(k) Clearance

Also marketed or referenced as:
CONTOUR3D Bending System
K253216 · Alphatec Spine, Inc. · Radiology device
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Jun 2026
Decision
269d
Days
-
Risk

K253216 is an FDA 510(k) clearance for the IntraOp Alignment System.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 25, 2026 after a review of 269 days - an extended review cycle.

This device falls under the Radiology 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K253216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 25, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 107d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SIN
Device Class -