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)

MAESTRO WRIST FRACTURE IMPLANT

K-Number: K080426 · 2008-07-29

ApplicantBiomet Manufacturing Corp
Decision Date2008-07-29
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAESTRO WRIST FRACTURE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2008-07-29 under 510(k) number K080426. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAESTRO WRIST FRACTURE IMPLANT?

MAESTRO WRIST FRACTURE IMPLANT is a medical device that received FDA 510(k) clearance on 2008-07-29. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K080426.

When did MAESTRO WRIST FRACTURE IMPLANT receive FDA 510(k) clearance?

MAESTRO WRIST FRACTURE IMPLANT received FDA 510(k) clearance on 2008-07-29, under 510(k) number K080426.

Who is the listed applicant for MAESTRO WRIST FRACTURE IMPLANT?

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

What is the FDA product code for MAESTRO WRIST FRACTURE IMPLANT?

The FDA product code for MAESTRO WRIST FRACTURE IMPLANT is JWJ.

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 Biomet Manufacturing 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.

K230540Patient Specific Planning Solution™ 3D Bone ModelsK214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemK211729Comprehensive® Convertible Glenoid - Vivacit-E LinerK202232Comprehensive Vault Reconstruction SystemK193038Comprehensive Shoulder SystemK182516Comprehensive Nano Stemless Shoulder

View all 82 devices →

Related Devices (Code: JWJ)

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.

K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.K233574Total Wrist Arthroplasty System (TWA)Skeletal DynamicsK233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLCK042032MAESTRO TOTAL WRISTBiomet, 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.

↑