FDA 510(k)

ATEC IOM Accessory Instruments

K-Number: K182617 · 2019-05-09

Decision Date2019-05-09

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 2019-05-09 under approval number K182617. 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 2019-05-09. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K182617.

When was ATEC IOM Accessory Instruments approved by the FDA?

ATEC IOM Accessory Instruments received FDA 510(k) clearance on 2019-05-09, under approval number K182617.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.