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FDA 510(k)

Calibrate Interbody Systems

K-Number: K243461 · 2025-03-04

ApplicantAlphatec Spine, Inc.
Decision Date2025-03-04
Product Code
DecisionSubstantially Equivalent

Device Summary

Calibrate Interbody Systems is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-03-04 under approval number K243461. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Calibrate Interbody Systems?

Calibrate Interbody Systems is a medical device that received FDA 510(k) clearance on 2025-03-04. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K243461.

When was Calibrate Interbody Systems approved by the FDA?

Calibrate Interbody Systems received FDA 510(k) clearance on 2025-03-04, under approval number K243461.

What company makes Calibrate Interbody Systems?

Calibrate Interbody Systems is manufactured by Alphatec Spine, Inc..

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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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