32mm BIOLOX delta Femoral Head, 12/14 taper, -3.5mm Head Length

GUDID 00814703011528

TOTAL JOINT ORTHOPEDICS, INC.

Ceramic femoral head prosthesis

Primary Device ID	00814703011528
NIH Device Record Key	c80c7613-bd38-4445-a3de-64afea870ed9
Commercial Distribution Status	In Commercial Distribution
Brand Name	32mm BIOLOX delta Femoral Head, 12/14 taper, -3.5mm Head Length
Version Model Number	3203.32.035
Company DUNS	078416717
Company Name	TOTAL JOINT ORTHOPEDICS, INC.
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

Customer Support Contacts

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

Device Dimensions

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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703011528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143407

FDA Product Code

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

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

[00814703011528]

Radiation Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-21

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