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)

Dynex Micro

K-Number: K202143 · 2020-09-11

ApplicantVilex, LLC
Decision Date2020-09-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dynex Micro is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K202143. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynex Micro?

Dynex Micro is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Vilex, LLC. The 510(k) number is K202143.

When did Dynex Micro receive FDA 510(k) clearance?

Dynex Micro received FDA 510(k) clearance on 2020-09-11, under 510(k) number K202143.

Who is the listed applicant for Dynex Micro?

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

What is the FDA product code for Dynex Micro?

The FDA product code for Dynex Micro is KTT.

Other records listing Vilex, LLC 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.

K260900DYNEX® External Fixation SystemsK250304TITANEX Screw SystemsK240475Hintermann Series H2 Total Ankle SystemK243408TACTIX Vector Syndesmosis SystemK233816REDEMPTION Charcot Plating SystemK240035TACTIX Vector Syndesmosis System

View all 17 devices →

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.

↑