Arcos® One-Piece Revision System 110024884
GUDID 00887868469503
Biomet Orthopedics, LLC
Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial| Primary Device ID | 00887868469503 |
| NIH Device Record Key | b80f541e-8477-4f33-a2cf-6ba1f6df5ff8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arcos® One-Piece Revision System |
| Version Model Number | 110024884 |
| Catalog Number | 110024884 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868469503 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151603
FDA Product Code
| KWL | Prosthesis, hip, hemi-, femoral, metal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
[00887868469503]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-02 |
| Device Publish Date | 2022-04-23 |
On-Brand Devices [Arcos® One-Piece Revision System]
Trademark Results [Arcos]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCOS 98001041 not registered Live/Pending |
HLI Solutions, Inc. 2023-05-17 |
 ARCOS 97567037 not registered Live/Pending |
Siman, Alvaro E. 2022-08-26 |
 ARCOS 97141919 not registered Live/Pending |
Hubbell Lighting, Inc. 2021-11-24 |
 ARCOS 88750745 not registered Live/Pending |
Arcos, Inc. 2020-01-08 |
 ARCOS 88500444 not registered Live/Pending |
Archimedes Controls Corp. 2019-07-03 |
 ARCOS 87601803 5577107 Live/Registered |
Arrcus, Inc. 2017-09-08 |
 ARCOS 87588350 not registered Dead/Abandoned |
SCOPERTA IMPORTING COMPANY 2017-08-29 |
 ARCOS 86823144 5392314 Live/Registered |
Dosamar Corporation 2015-11-17 |
 ARCOS 86114301 not registered Dead/Abandoned |
Smith, Logan 2013-11-08 |
 ARCOS 85801573 4379613 Live/Registered |
ARCOS, LLC 2012-12-13 |
 ARCOS 85801564 4379612 Live/Registered |
ARCOS, LLC 2012-12-13 |
 ARCOS 85801551 4570680 Live/Registered |
ARCOS, INC. 2012-12-13 |
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