PROFEMUR® PLLES015
GUDID M684PLLES0151
PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 15 EXT LONG NECK
Microport Orthopedics Inc.
Press-fit femoral stem prosthesis| Primary Device ID | M684PLLES0151 |
| NIH Device Record Key | e0bf071c-6648-4660-b8cf-12601af0a367 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROFEMUR® |
| Version Model Number | PLLES015 |
| Catalog Number | PLLES015 |
| 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 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192629116368 [Primary] |
| HIBCC | M684PLLES0151 [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 |
Trademark Results [PROFEMUR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFEMUR 76380670 2692765 Live/Registered |
Wright Medical Technology, Inc. 2002-03-11 |
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