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510(k) K201072

Device
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
Applicant
Ensemble Orthopedics, LLC
510(k) number
K201072
Product code
KYI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-02
Date received
2020-04-22
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
Sandie Roth
Address
107 Redbud Trl., Suite 11 Austin TX US 78746 78746

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
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
K965204AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANTAvanta Orthopaedics, Inc.1997-06-03

Legacy Summary#

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FDA Review#

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