Profemur PGHCCLE6

GUDID M684PGHCCLE61

PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT

Microport Orthopedics Inc.

Revision coated hip femur prosthesis

• Primary Device ID: M684PGHCCLE61
• NIH Device Record Key: 7af400a4-3603-4f20-bba6-306b0ca598b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profemur
• Version Model Number: PGHCCLE6
• Catalog Number: PGHCCLE6
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192629250369 [Primary]
HIBCC	M684PGHCCLE61 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200007

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Profemur]

• M684PGHCCS101: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 STD
• M684PGHCCLE71: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 EXT
• M684PGHCCE101: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 10 EXT
• M684PGHCCLE91: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 EXT
• M684PGHCCLE81: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 EXT
• M684PGHCCLE61: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 EXT
• M684PGHCCLE51: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 EXT
• M684PGHCCLE41: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 EXT
• M684PGHCCLE31: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 EXT
• M684PGHCCLE21: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 EXT
• M684PGHCCLE11: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 EXT
• M684PGHCCLS91: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 9 STD
• M684PGHCCLS81: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 8 STD
• M684PGHCCLS71: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 7 STD
• M684PGHCCLS61: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 6 STD
• M684PGHCCLS51: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 5 STD
• M684PGHCCLS41: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 4 STD
• M684PGHCCLS31: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 3 STD
• M684PGHCCLS21: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 2 STD
• M684PGHCCLS11: PROFEMUR® GLADIATOR® THIN HA CLASSIC W/COLLAR SIZE 1 STD
• M684PRGCME121: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 12 EXTENDED
• M684PRGCME101: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 10 EXTENDED
• M684PRGCMS121: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 12 STANDARD
• M684PRGCMS101: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 10 STANDARD
• M684PRGCCME81: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 8 EXTENDED
• M684PRGCCME61: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 6 EXTENDED
• M684PRGCCME41: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 4 EXTENDED
• M684PRGCCMS81: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 8 STANDARD
• M684PRGCCMS61: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 6 STANDARD
• M684PRGCCMS41: PROFEMUR® GLADIATOR® CEMENTED CLASSIC STEM SIZE 4 STANDARD
• 00192629063945: PROFEMUR RENAISSANCE STEM STANDARD SZ 18
• M684PLS0S4171: PROFEMUR RENAISSANCE STEM STANDARD SZ 17
• M684PLS0S4161: PROFEMUR RENAISSANCE STEM STANDARD SZ 16
• M684PLS0S4151: PROFEMUR RENAISSANCE STEM STANDARD SZ 15
• 00192629061354: PROFEMUR RENAISSANCE STEM STANDARD SZ 14
• M684PLS0S4131: PROFEMUR RENAISSANCE STEM STANDARD SZ 13
• 00192629061330: PROFEMUR RENAISSANCE STEM STANDARD SZ 12
• M684PLS0S4111: PROFEMUR RENAISSANCE STEM STANDARD SZ 11
• 00192629061316: PROFEMUR RENAISSANCE STEM STANDARD SZ 10
• 00192629061309: PROFEMUR RENAISSANCE STEM REDUCED SZ 16
• M684PLS0R4151: PROFEMUR RENAISSANCE STEMREDUCED SZ 15
• 00192629061286: PROFEMUR RENAISSANCE STEMREDUCED SZ 14
• 00192629061279: PROFEMUR RENAISSANCE STEM REDUCED SZ 13
• 00192629061262: PROFEMUR RENAISSANCE STEM REDUCED SZ 12
• 00192629061255: PROFEMUR RENAISSANCE STEM REDUCED SZ 11
• M684PLS0R4101: PROFEMUR RENAISSANCE STEM REDUCED SZ 10
• M684BROHANPL1: PROFEMUR BROACH HANDLE REPLACEMENT PLUNGER ASSEMBLY