FDA.reportPublic FDA data

510(k) K960534

Device
Metallic Spherical Cmc Implant
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) number
K960534
Product code
KYI
Decision
Substantially Equivalent (SESE)
Decision date
1997-02-06
Date received
1996-02-07
Regulation
888.3770
Classification name
Prosthesis, Wrist, Carpal Trapezium
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CLIFF R KLINE II
Address
5677 Airline Rd. Arlington TN US 38002 38002

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC2020-12-02
K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC2018-04-11
K111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLC2011-12-30
K112278ASCENSION NUGRIP CMC IMPLANTAscension Orthopedic2011-11-04
K092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLC2009-12-15
K061956ARTELON STT SPACERArtimplant AB2007-06-07
K061954ARTELON CMC SPACER ARTHROArtimplant AB2007-06-01
K061451ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc.2006-08-11
K061089MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599Biopro, Inc.2006-06-20
K060386NEXA CARPO METACARPAL IMPLANTNexa Orthopedics, Inc.2006-05-10
K052596MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507Biopro, Inc.2005-11-15
K042690ASCENSION PYROSPHERE (PCS)Ascension Orthopedics, Inc.2004-11-13
K040070ARTELON SPACER CMC-1Artimplant AB2004-09-21
K041451ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc.2004-08-25
K033529TIE-IN TRAPEZIUMWrightmedicaltechnologyinc2003-12-03