Quadra C Femoral Stems

GUDID 07630030802911

Quadra C Cemented Stem Lateralized size 6 Short Neck

Medacta International SA

Uncoated hip femur prosthesis, one-piece

Primary Device ID	07630030802911
NIH Device Record Key	e4a41f41-451c-453d-9076-786df1d43de0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Quadra C Femoral Stems
Version Model Number	01.12.56SN
Company DUNS	488227125
Company Name	Medacta International SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030802911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K103189

FDA Product Code

LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-11-18

On-Brand Devices [Quadra C Femoral Stems]

07630030802928	Quadra C Cemented Stem Lateralized size 7 Short Neck
07630030802911	Quadra C Cemented Stem Lateralized size 6 Short Neck
07630030802904	Quadra C Cemented Stem Lateralized size 5 Short Neck
07630030802898	Quadra C Cemented Stem Lateralized size 4 Short Neck
07630030802881	Quadra C Cemented Stem Lateralized size 3 Short Neck
07630030802874	Quadra C Cemented Stem Lateralized size 2 Short Neck
07630030802867	Quadra C Cemented Stem Lateralized size 1 Short Neck
07630030802850	Quadra C Cemented Stem Standard size 7 Short Neck
07630030802843	Quadra C Cemented Stem Standard size 6 Short Neck
07630030802836	Quadra C Cemented Stem Standard size 5 Short Neck
07630030802829	Quadra C Cemented Stem Standard size 4 Short Neck
07630030802812	Quadra C Cemented Stem Standard size 3 Short Neck
07630030802805	Quadra C Cemented Stem Standard size 2 Short Neck
07630030802799	Quadra C Cemented Stem Standard size 1 Short Neck
07630030802782	Quadra C Cemented Stem Standard size 0 Short Neck
07630030802362	Quadra C Cemented Lateralized stem size 7
07630030802355	Quadra C Cemented Lateralized stem size 6
07630030802348	Quadra C Cemented Lateralized stem size 5
07630030802331	Quadra C Cemented Lateralized stem size 4
07630030802324	Quadra C Cemented Lateralized stem size 3
07630030802317	Quadra C Cemented Lateralized stem size 2
07630030802300	Quadra C Cemented Lateralized stem size 1
07630030802287	Quadra C Cemented Standard stem size 7
07630030802270	Quadra C Cemented Standard stem size 6
07630030802263	Quadra C Cemented Standard stem size 5
07630030802256	Quadra C Cemented Standard stem size 4
07630030802249	Quadra C Cemented Standard stem size 3
07630030802232	Quadra C Cemented Standard stem size 2
07630030802225	Quadra C Cemented Standard stem size 1
07630030802218	Quadra C Cemented Standard stem size 0