Klassic HD Acetabular Insert with E-Link Poly

GUDID 00814703015014

Acetabular Insert with E-Link Poly, 28mm head, size 46mm

TOTAL JOINT ORTHOPEDICS, INC.

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner

• Primary Device ID: 00814703015014
• NIH Device Record Key: ca9965b5-ac92-470e-96f0-29d40badfe95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic HD Acetabular Insert with E-Link Poly
• Version Model Number: 3502.46.028
• 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

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	00814703015014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180929

FDA Product Code

• MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

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

[00814703015014]

Ethylene Oxide

[00814703015014]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-13
• Device Publish Date: 2018-06-12

On-Brand Devices [Klassic HD Acetabular Insert with E-Link Poly ]

• 00814703015014: Acetabular Insert with E-Link Poly, 28mm head, size 46mm
• 00814703015007: Acetabular Insert with E-Link Poly, 28mm head, size 44mm
• 00814703014994: Acetabular Insert with E-Link Poly, 22mm head, size 46mm
• 00814703014987: Acetabular Insert with E-Link Poly, 22mm head, size 44mm