PROFEMUR TL2 PRTL2SP8

GUDID M684PRTL2SP81

PROFEMUR TL2 STEM SZ 8+ STANDARD NECK

Microport Orthopedics Inc.

Press-fit femoral stem prosthesis

• Primary Device ID: M684PRTL2SP81
• NIH Device Record Key: 2718f29e-0d5f-45b3-a5e4-e806bb43fba4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFEMUR TL2
• Version Model Number: PRTL2SP8
• Catalog Number: PRTL2SP8
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192629396128 [Primary]
HIBCC	M684PRTL2SP81 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191632

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [PROFEMUR TL2]

• M684PRTL2BP91: PROFEMUR TL2 BROACH SZ 9+
• M684PRTL2BP81: PROFEMUR TL2 BROACH SZ 8+
• M684PRTL2BP51: PROFEMUR TL2 BROACH SZ 5+
• M684PRTL2EP91: PROFEMUR® TL2 STEM SZ 9+ HIGH OFFSET NECK
• M684PRTL2EP81: PROFEMUR® TL2 STEM SZ 8+ HIGH OFFSET NECK
• M684PRTL2EP51: PROFEMUR TL2 STEM SZ 5+ HIGH OFFSET NECK
• M684PRTL2SP91: PROFEMUR TL2 STEM SZ 9+ STANDARD NECK
• M684PRTL2SP81: PROFEMUR TL2 STEM SZ 8+ STANDARD NECK
• M684PRTL2SP51: PROFEMUR TL2 STEM SZ 5+ STANDARD NECK