FDA.report

ORTHOLOC®

Primary DI
18450240
Brand
ORTHOLOC®
Company
Microport Orthopedics Inc.
Model
18450240
Catalog number
18450240
Device description
ORTHOLOC® II PLASTIC PATELLA 35mm, SM
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18450240Direct MarkingHIBCC0
M684184502401PrimaryHIBCC0

GMDN Terms

TermDefinition
Polyethylene patella prosthesisAn implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.

Device Sizes

TypeValueUnit
Outer Diameter35Millimeter

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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