Acetabular Insert with ApeX-Lnk Poly, 36mm Head, Size 54mm

GUDID 00814703012488

TOTAL JOINT ORTHOPEDICS, INC.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00814703012488
• NIH Device Record Key: bab8cb0d-8c2b-4b69-8567-25c02d9d2d36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetabular Insert with ApeX-Lnk Poly, 36mm Head, Size 54mm
• Version Model Number: 3501.54.036
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703012488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100445

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814703012488]

Ethylene Oxide

[00814703012488]

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: 2015-10-21

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