Klassic Blade Femoral Stem

GUDID 00814703013577

Blade Femoral Stem, Porous, size 12

TOTAL JOINT ORTHOPEDICS, INC.

Press-fit hip femur prosthesis, one-piece
Primary Device ID00814703013577
NIH Device Record Key7d460a8f-860c-4d62-a95d-97cd0e1286b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic Blade Femoral Stem
Version Model Number3105.12.000
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703013577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703013577]

Radiation Sterilization


[00814703013577]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-31

On-Brand Devices [Klassic Blade Femoral Stem ]

00814703013577Blade Femoral Stem, Porous, size 12
00814703013560Blade Femoral Stem, Porous, size 11
00814703013553Blade Femoral Stem, Porous, size 10

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