PROFEMUR® PLLER010

GUDID M684PLLER0101

PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 10 EXT LONG NECK

Microport Orthopedics Inc.

Press-fit femoral stem prosthesis

• Primary Device ID: M684PLLER0101
• NIH Device Record Key: c9436502-e654-4457-a174-a77c8fda91b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFEMUR®
• Version Model Number: PLLER010
• Catalog Number: PLLER010
• 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
• 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	00192629116177 [Primary]
HIBCC	M684PLLER0101 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141235

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

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: 2022-03-08
• Device Publish Date: 2022-02-28

On-Brand Devices [PROFEMUR®]

• M684PPW380741: PROFEMUR® PROX BODY RASP STD 4
• M684PPW380731: PROFEMUR® PROX BODY RASP STD 3
• M684PPW380721: PROFEMUR® PROX BODY RASP STD 2
• M684PPW380711: PROFEMUR® PROX BODY RASP STD 1
• 00192629116481: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 18 STD LONG NECK
• 00192629116474: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 17 STD LONG NECK
• 00192629116467: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 16 STD LONG NECK
• M684PLLSS0151: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 15 STD LONG NECK
• 00192629116443: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 14 STD LONG NECK
• M684PLLSS0131: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 13 STD LONG NECK
• 00192629116429: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 STD LONG NECK
• 00192629116412: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 11 STD LONG NECK
• M684PLLSS0101: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 10 STD LONG NECK
• 00192629116399: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 18 EXT LONG NECK
• M684PLLES0171: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 17 EXT LONG NECK
• M684PLLES0161: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 16 EXT LONG NECK
• M684PLLES0151: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 15 EXT LONG NECK
• 00192629116351: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 14 EXT LONG NECK
• 00192629116344: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 13 EXT LONG NECK
• M684PLLES0121: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 EXT LONG NECK
• 00192629116320: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 11 EXT LONG NECK
• M684PLLES0101: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 10 EXT LONG NECK
• 00192629116306: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 16 STD LONG NECK
• 00192629116290: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 15 STD LONG NECK
• M684PLLSR0141: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 14 STD LONG NECK
• 00192629116276: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 13 STD LONG NECK
• 00192629116269: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 12 STD LONG NECK
• 00192629116252: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 11 STD LONG NECK
• M684PLLSR0101: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 10 STD LONG NECK
• M684PLLER0161: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 16 EXT LONG NECK
• M684PLLER0151: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 15 EXT LONG NECK
• M684PLLER0141: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 14 EXT LONG NECK
• 00192629116207: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 13 EXT LONG NECK
• M684PLLER0121: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 12 EXT LONG NECK
• 00192629116184: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 11 EXT LONG NECK
• M684PLLER0101: PROFEMUR® RENAISSANCE® CLASSIC RDC FLARE SZ 10 EXT LONG NECK
• M684PLSSS0181: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 18 STD SHORT NECK
• M684PLSSS0171: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 17 STD SHORT NECK
• M684PLSSS0161: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 16 STD SHORT NECK
• 00192629114531: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 15 STD SHORT NECK
• 00192629114524: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 14 STD SHORT NECK
• M684PLSSS0131: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 13 STD SHORT NECK
• 00192629114500: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 STD SHORT NECK
• 00192629114494: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 11 STD SHORT NECK
• M684PLSSS0101: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 10 STD SHORT NECK
• 00192629114470: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 18 EXT SHORT NECK
• M684PLSES0171: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 17 EXT SHORT NECK
• M684PLSES0161: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 16 EXT SHORT NECK
• 00192629114449: PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 15 EXT SHORT NECK