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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 a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-05-22 under approval 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. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K240199.

When was IntraOp Alignment System approved by the FDA?

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

What company makes IntraOp Alignment System?

IntraOp Alignment System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for IntraOp Alignment System?

The FDA product code for IntraOp Alignment System is OWB.

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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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