Quatro-M Femoral Stem WK-1-1014

GUDID B046WK110140

Quatro-M Femoral Stem 3M

SIGNAL MEDICAL CORPORATION

Press-fit hip femur prosthesis, one-piece
Primary Device IDB046WK110140
NIH Device Record Key2167fb2d-453f-4094-a9f5-7ada04e82d2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuatro-M Femoral Stem
Version Model Number3M
Catalog NumberWK-1-1014
Company DUNS169289308
Company NameSIGNAL MEDICAL CORPORATION
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone810-364-7070
Emailjgorney@signalmd.com
Phone810-364-7070
Emailjgorney@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB046WK110140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-24

On-Brand Devices [Quatro-M Femoral Stem]

B046WK110330Quatro-M Femoral Stem 4XS
B046WK110320Quatro-M Femoral Stem 3XS
B046WK110310Quatro-M Femoral Stem 2XS
B046WK110230Quatro-M Femoral Stem 5L
B046WK110220Quatro-M Femoral Stem 5M
B046WK110210Quatro-M Femoral Stem 5S
B046WK110200Quatro-M Femoral Stem 4XL
B046WK110190Quatro-M Femoral Stem 4L
B046WK110170Quatro-M Femoral Stem 4S
B046WK110160Quatro-M Femoral Stem 3XL
B046WK110150Quatro-M Femoral Stem 3L
B046WK110140Quatro-M Femoral Stem 3M
B046WK110130Quatro-M Femoral Stem 3S
B046WK11011Quatro-M Femoral Stem 2L
B046WK11010Quatro-M Femoral Stem 2M
B046WK110090Quatro-M Femoral Stem 2S
B046WK110340Quatro-M Femoral Stem 5XS
B046WK110180Quatro-M Femoral Stem 4M
B046WK110240Quatro-M Femoral Stem 5XL
B046WK110120Quatro-M Femoral Stem 2XL

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