FDA 510(k)

ATEC IOM Accessory Instruments

K-Number: K221821 · 2022-09-23

Decision Date2022-09-23

Product CodePDQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ATEC IOM Accessory Instruments is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2022-09-23 under approval number K221821. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATEC IOM Accessory Instruments?

ATEC IOM Accessory Instruments is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K221821.

When was ATEC IOM Accessory Instruments approved by the FDA?

ATEC IOM Accessory Instruments received FDA 510(k) clearance on 2022-09-23, under approval number K221821.

What company makes ATEC IOM Accessory Instruments?

ATEC IOM Accessory Instruments is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC IOM Accessory Instruments?

The FDA product code for ATEC IOM Accessory Instruments is PDQ.

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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.