COPAL® exchange G 5034797

GUDID 04260102136960

The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.

Heraeus Medical GmbH

Orthopaedic cement spacer
Primary Device ID04260102136960
NIH Device Record Keyf5ca5377-a196-4cea-8caf-2e31af871a1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOPAL® exchange G
Version Model Numberknee M
Catalog Number5034797
Company DUNS333623937
Company NameHeraeus Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260102136946 [Primary]
GS104260102136953 [Package]
Contains: 04260102136946
Package: Carton box [12 Units]
In Commercial Distribution
GS104260102136960 [Package]
Contains: 04260102136946
Package: Pallet [144 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-10
Device Publish Date2019-12-02

On-Brand Devices [COPAL® exchange G]

04260102136991The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136960The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136939The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102130609COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102131149COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102131132COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102130814COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102130807COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102139220COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
04260102139190COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
04260102136885The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136878The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136847The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136816The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136786The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136755The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136724The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136694The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev

Trademark Results [COPAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COPAL
COPAL
97715895 not registered Live/Pending
In Mocean Group LLC
2022-12-13
COPAL
COPAL
79225667 5663402 Live/Registered
Krzysztof Bawol
2017-08-21
COPAL
COPAL
79131038 4473176 Live/Registered
NIDEC COPAL CORPORATION
2013-04-15
COPAL
COPAL
77913448 3834767 Dead/Cancelled
Thiem, Hannah L
2010-01-16
COPAL
COPAL
77882561 not registered Dead/Abandoned
Chokron, Melanie
2009-11-30
COPAL
COPAL
77655389 not registered Dead/Abandoned
Chokron, Melanie
2009-01-23
COPAL
COPAL
76712615 4445460 Live/Registered
Heraeus Medical GmbH
2012-10-12
COPAL
COPAL
76628054 3134732 Dead/Cancelled
Heraeus Kulzer GmbH
2005-01-18
COPAL
COPAL
75642936 not registered Dead/Abandoned
Maruba Therapy, Inc.
1999-02-16
COPAL
COPAL
75416593 2228206 Dead/Cancelled
Merck KGaA, Kommanditgesellschaft auf Aktien
1998-01-12
COPAL
COPAL
75196772 not registered Dead/Abandoned
Maruba Therapy, Inc.
1996-11-12
COPAL
COPAL
74548595 1982985 Live/Registered
ADOBE INC.
1994-07-05

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