Duns Number:333623937
Device Description: COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) 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.COPAL® exchange G hip 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. COPAL® exchange G hip spacers are made with bone cement containing gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip 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.COPAL® exchange G hip spacers are intended for single-use and are supplied sterile.
Catalog Number
5147216
Brand Name
COPAL® exchange G
Version/Model Number
hip M medium
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
KWL
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Public Device Record Key
f3edc2dd-9b8b-4e1a-954c-fe1bf973e7a2
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 15, 2022
Package DI Number
04260102139220
Quantity per Package
144
Contains DI Package
04260102139206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |