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)

SPIRIT

K-Number: K896913 · 1990-03-08

ApplicantOrmco Corp.
Decision Date1990-03-08
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPIRIT is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1990-03-08 under 510(k) number K896913. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRIT?

SPIRIT is a medical device that received FDA 510(k) clearance on 1990-03-08. The listed applicant is Ormco Corp.. The 510(k) number is K896913.

When did SPIRIT receive FDA 510(k) clearance?

SPIRIT received FDA 510(k) clearance on 1990-03-08, under 510(k) number K896913.

Who is the listed applicant for SPIRIT?

The FDA 510(k) record lists Ormco Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRIT?

The FDA product code for SPIRIT is DYW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ormco Corp. 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.

K123118INSIGNIA DIGICASTK123416INSIGNIA WITH ITEROK122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEK121524INSIGNIAK112640HYPERELASTIC WIREK101676CLEARARCH

View all 39 devices →

Related Devices (Code: DYW)

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.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.

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.

↑