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510(k) K112802

Device
PIPELINE TOTAL HIP SYSTEM
Applicant
PIPELINE ORTHOPEDICS
510(k) number
K112802
Product code
OQG  
Decision
Substantially Equivalent (SESE)
Decision date
2012-03-09
Date received
2011-09-27
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TERRY POWELL
Address
901 King St., Suite 200 Alexandria VA US 22314 22314

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
K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.2020-03-11
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

Legacy Summary#

summary

FDA Review#

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