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)

UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)

K-Number: K961051 · 1996-06-06

ApplicantKinetikos Medical, Inc.
Decision Date1996-06-06
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 1996-06-06 under 510(k) number K961051. 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 UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)?

UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-06-06. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K961051.

When did UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) receive FDA 510(k) clearance?

UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) received FDA 510(k) clearance on 1996-06-06, under 510(k) number K961051.

Who is the listed applicant for UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)?

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

What is the FDA product code for UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)?

The FDA product code for UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) 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 Kinetikos Medical, 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.

K061749ECLIPSE TOTAL ANKLE IMPLANTK061465KMI CEMENT RESTRICTOR IMPLANTK051611MBARESORB IMPLANTK041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMK032806KATALYST RADIAL HEAD IMPLANTK040356KOMPRESSOR SCREW SYSTEM

View all 19 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, LLCK080426MAESTRO WRIST FRACTURE IMPLANTBiomet Manufacturing Corp

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.

↑