COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers - Heraeus Medical GmbH

Duns Number:333623937

Device Description: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stag 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.

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More Product Details

Catalog Number

5034798

Brand Name

COPAL® exchange G

Version/Model Number

knee S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191016,K191016,K191016

Product Code Details

Product Code

JWH

Product Code Name

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

Device Record Status

Public Device Record Key

a96d16eb-ace1-470f-88eb-311f3dbb0762

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Additional Identifiers

Package DI Number

04260102136939

Quantity per Package

144

Contains DI Package

04260102136915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet

"HERAEUS MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 4