ClearanceBrief
Panels › Orthopedic › Product code OQG · Class 2

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Regulation 888.3358

0510(k)s in 12 months (20 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in OQG

Decided510(k)Device and applicantCode
Aug 20, 2021K202705Prime and DYNASTY® Additive Manufacturing Shells
Microport Orthopedics, Inc.
OQG
Apr 2, 2021K203472KMTI Hip Replacement System
Kyocera Medical Technologies, Inc.
OQG
Jul 16, 2020K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.
OQG
Mar 11, 2020K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.
OQG
Dec 13, 2017K172651FMP Extended Liners
Encore Medical L.P.
OQG
Nov 16, 2017K171543Renovis Surgical Hip Replacement System
Renovis Surgical Technologies
OQG
Oct 27, 2017K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly
Total Joint Orthopedics, Inc.
OQG
May 11, 2015K143647Renovis Surgical Hip Replacement System
Renovis Surgical Technologies, Inc.
OQG
Nov 6, 2014K140130X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
Encore Medical L.P.
OQG
Oct 9, 2014K141972KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY
Total Joint Orthopedics, Inc.
OQG
Jun 27, 2014K140701NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
Novosource, Inc.
OQG
Dec 17, 2013K130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
Consensus Orthopedics, Inc.
OQG
Oct 30, 2013K122783PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
Aesculap Implant System, Inc.
OQG
Sep 23, 2013K130365X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
Encore Medical L.P.
OQG
Dec 11, 2012K122158PBP TOTAL HIP SYSTEM
Pipeline Biomedical Products, LLC
OQG
Oct 9, 2012K122773CROSS-OVER ACETABULAR SHELL & LINER
Stelkast Company
OQG
Jun 13, 2012K112897RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
Renovis Surgical Technologies, LLC
OQG
Jun 4, 2012K120370VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
Zimmer, Inc.
OQG
Mar 9, 2012K112802PIPELINE TOTAL HIP SYSTEM
Pipeline Orthopedics
OQG
Mar 24, 2011K094035EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
Stelkast Company
OQG

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