Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AUTOALIGN

K-Number: K021191 · 2002-07-12

Decision Date2002-07-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUTOALIGN is the device name listed in this FDA 510(k) record. The listed applicant is Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021191. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOALIGN?

AUTOALIGN is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K021191.

When did AUTOALIGN receive FDA 510(k) clearance?

AUTOALIGN received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021191.

Who is the listed applicant for AUTOALIGN?

The FDA 510(k) record lists Cortechs Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOALIGN?

The FDA product code for AUTOALIGN is LLZ.

Related Clinical Trials

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.

Other records listing Cortechs Labs, Inc. as applicant

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.

View all 8 devices →

Related Devices (Code: LLZ)

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.

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.

↑