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510(k) K200328

Device
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Applicant
Kyocera Medical Technologies, Inc.
510(k) number
K200328
Product code
OQG  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-11
Date received
2020-02-10
Regulation
888.3358
Classification name
Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anthony DeBenedictis
Address
1200 California St. Suite 210 Redlands CA US 92374 92374

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202705Prime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.2021-08-20
K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.2021-04-02
K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.2020-07-16
K172651FMP Extended LinersEncore Medical L.P.2017-12-13
K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies2017-11-16
K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc.2017-10-27
K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.2015-05-11
K140130X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODEDEncore Medical L.P.2014-11-06
K141972KLASSIC HD ACETABULAR INSERT WITH E-LINK POLYTotal Joint Orthopedics, Inc.2014-10-09
K140701NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGNovosource, Inc.2014-06-27
K130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTConsensus Orthopedics, Inc.2013-12-17
K122783PLASMAFIT ACETABULAR CUP AND VITELENE INSERTAesculap Implant System, Inc.2013-10-30
K130365X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINEREncore Medical L.P.2013-09-23
K122158PBP TOTAL HIP SYSTEMPipeline Biomedical Products, LLC2012-12-11
K122773CROSS-OVER ACETABULAR SHELL & LINERStelkast Company2012-10-09

Legacy Summary#

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FDA Review#

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