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FDA 510(k)

ATEC IOM Accessory Instruments

K-Number: K191723 · 2019-10-18

ApplicantAlphatec Spine, Inc.
Decision Date2019-10-18
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ATEC IOM Accessory Instruments 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 2019-10-18 under 510(k) number K191723. 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 2019-10-18. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K191723.

When did ATEC IOM Accessory Instruments receive FDA 510(k) clearance?

ATEC IOM Accessory Instruments received FDA 510(k) clearance on 2019-10-18, under 510(k) number K191723.

Who is the listed applicant for ATEC IOM Accessory Instruments?

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 ATEC IOM Accessory Instruments?

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

Other records listing Alphatec Spine, Inc. as applicant

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Related Devices (Code: PDQ)

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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