Orthinox 6364-2-036

GUDID 07613153121992

V40 Femoral head

Howmedica Osteonics Corp.

Metallic femoral head prosthesis
Primary Device ID07613153121992
NIH Device Record Keyf409d47e-a324-46fb-80f7-5e4a274c0e6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthinox
Version Model Number6364-2-036
Catalog Number6364-2-036
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Outer Diameter36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613153121992 [Primary]

FDA Product Code

MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-06
Device Publish Date2015-09-24

On-Brand Devices [Orthinox]

07613153122012V40 Femoral head
07613153122005V40 Femoral head
07613153121992V40 Femoral head
04546540402189V40 FEM HEAD
04546540402172V40 FEM HEAD
04546540402165V40 FEM HEAD
04546540402158V40 FEM HEAD
04546540273390V40 FEM HEAD
04546540273383V40 Femoral head
04546540273369V40 FEM HEAD
04546540273345V40 FEM HEAD
04546540273338V40 Femoral head
04546540273321V40 FEM HEAD
04546540273314V40 FEM HEAD
04546540273307V40 FEM HEAD
04546540273291V40 FEM HEAD
04546540273284V40 Femoral head
04546540273277V40 FEM HEAD
04546540273260V40 FEM HEAD
04546540273376V40 FEM HEAD

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