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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 the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2025-03-04 under 510(k) 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. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K243461.

When did Calibrate Interbody Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Calibrate Interbody Systems?

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

Other records listing Alphatec Spine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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