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FDA 510(k)

IntraOp Alignment System

K-Number: K240199 · 2024-05-22

ApplicantAlphatec Spine, Inc.
Decision Date2024-05-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IntraOp Alignment 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 2024-05-22 under 510(k) number K240199. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraOp Alignment System?

IntraOp Alignment System is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K240199.

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

IntraOp Alignment System received FDA 510(k) clearance on 2024-05-22, under 510(k) number K240199.

Who is the listed applicant for IntraOp Alignment 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?

The FDA product code for IntraOp Alignment System is OWB.

Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: OWB)

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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