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FDA 510(k)

PHALANGEAL FIXATION SYSTEM

K-Number: K994232 · 2000-03-01

ApplicantMedcanica, Inc.
Decision Date2000-03-01
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHALANGEAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medcanica, Inc.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K994232. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHALANGEAL FIXATION SYSTEM?

PHALANGEAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is Medcanica, Inc.. The 510(k) number is K994232.

When did PHALANGEAL FIXATION SYSTEM receive FDA 510(k) clearance?

PHALANGEAL FIXATION SYSTEM received FDA 510(k) clearance on 2000-03-01, under 510(k) number K994232.

Who is the listed applicant for PHALANGEAL FIXATION SYSTEM?

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

What is the FDA product code for PHALANGEAL FIXATION SYSTEM?

The FDA product code for PHALANGEAL FIXATION SYSTEM is HTY.

Related Clinical Trials

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Other records listing Medcanica, 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.

K011373INSTRUMENT DAMPING PORTK011349INTERCOSTAL LOCKABLE-DIRECTABLE PORTK991486ULTRA-CBXK991064METACARPAL FIXATION SYSTEM

Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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