Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head

GUDID 00814703017483

Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head, +10.5mm head length

TOTAL JOINT ORTHOPEDICS, INC.

Femoral head/stem prosthesis adaptor

Primary Device ID	00814703017483
NIH Device Record Key	635de555-f1fa-4b99-bae0-2374de9066a8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Femoral Head Adapter Sleeve for BIOLOX OPTION Femoral Head
Version Model Number	3301.00.105
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
Phone	+1(801)486-6070
Email	udi@tjoinc.com

Device Dimensions

Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter
Length	10.5 Millimeter

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
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	00814703017483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213580

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

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

[00814703017483]

Radiation Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-12-23
Device Publish Date	2021-12-15

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