Klassic BiPolar Head, 54 mm OD, 28 mm Head

GUDID 00814703012068

TOTAL JOINT ORTHOPEDICS, INC.

Femoral head bipolar component

Primary Device ID	00814703012068
NIH Device Record Key	7cd809d5-2346-4587-b7cd-cae340d61b77
Commercial Distribution Status	In Commercial Distribution
Brand Name	Klassic BiPolar Head, 54 mm OD, 28 mm Head
Version Model Number	3205.54.028
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

Device Size Text, specify	0
Device Size Text, specify	0
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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
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 BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify	Between 0 and 0 *The Klassic BiPolar System Implants should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703012068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K143113

FDA Product Code

KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

[00814703012068]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-22

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