Klassic Blade Offset Femoral Stem

GUDID 00814703013584

Blade Offset Femoral Stem, Porous, size 10

TOTAL JOINT ORTHOPEDICS, INC.

Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 00814703013584
• NIH Device Record Key: 175d7de4-3eee-41b5-aa81-d16319b6ef63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Blade Offset Femoral Stem
• Version Model Number: 3107.10.000
• 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	00814703013584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171962

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00814703013584]

Radiation Sterilization

[00814703013584]

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: 2017-08-31

On-Brand Devices [Klassic Blade Offset Femoral Stem ]

• 00814703013607: Blade Offset Femoral Stem, Porous, size 12
• 00814703013591: Blade Offset Femoral Stem, Porous, size 11
• 00814703013584: Blade Offset Femoral Stem, Porous, size 10