Cleared Traditional

K253216 - IntraOp Alignment System

Also marketed or referenced as:
CONTOUR3D Bending System
K253216 · Alphatec Spine, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K253216

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 107d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

SIN Device Classification - Class ,

Product Code SIN
Device Class -