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FDA 510(k)

IntraOp Alignment System; CONTOUR3D Bending System

K-Number: K253216 · 2026-06-25

ApplicantAlphatec Spine, Inc.
Decision Date2026-06-25
Product CodeSIN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IntraOp Alignment System; CONTOUR3D Bending System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253216. The device is classified under product code SIN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraOp Alignment System; CONTOUR3D Bending System?

IntraOp Alignment System; CONTOUR3D Bending System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K253216.

When did IntraOp Alignment System; CONTOUR3D Bending System receive FDA 510(k) clearance?

IntraOp Alignment System; CONTOUR3D Bending System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253216.

Who is the listed applicant for IntraOp Alignment System; CONTOUR3D Bending System?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntraOp Alignment System; CONTOUR3D Bending System?

The FDA product code for IntraOp Alignment System; CONTOUR3D Bending System is SIN.

Other records listing Alphatec Spine, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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