FDA.report

CONSERVE®

Primary DI
38CH4810
Brand
CONSERVE®
Company
Microport Orthopedics Inc.
Model
38CH4810
Catalog number
38CH4810
Device description
CONSERVE® TOTAL 48MM BCH® FEMORAL HEAD
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
38CH4810Direct MarkingHIBCC0
M68438CH48101PrimaryHIBCC0

GMDN Terms

TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes

TypeValueUnit
Outer Diameter48Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-866-872-0211customerservice2@ortho.microport.com

Regulatory Flags

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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