Arcos® Modular Revision System 31-301343

GUDID 00887868476709

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00887868476709
• NIH Device Record Key: 1e9096af-f82e-4e8f-8370-96b9edb7d4b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arcos® Modular Revision System
• Version Model Number: 31-301343
• Catalog Number: 31-301343
• 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
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868476709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100469

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

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

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

[00887868476709]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [Arcos® Modular Revision System]

• 00887868478628: 31-311355
• 00887868478611: 31-311354
• 00887868478604: 31-311353
• 00887868478598: 31-311352
• 00887868478581: 31-311351
• 00887868478574: 31-311345
• 00887868478567: 31-311344
• 00887868478550: 31-311343
• 00887868478543: 31-311342
• 00887868478536: 31-311341
• 00887868478529: 31-311335
• 00887868478512: 31-311334
• 00887868478505: 31-311333
• 00887868478499: 31-311332
• 00887868478482: 31-311331
• 00887868478475: 31-311325
• 00887868478468: 31-311324
• 00887868478451: 31-311323
• 00887868478444: 31-311322
• 00887868478437: 31-311321
• 00887868478420: 31-311315
• 00887868478413: 31-311314
• 00887868478406: 31-311313
• 00887868478390: 31-311312
• 00887868478383: 31-311311
• 00887868478376: 31-311310
• 00887868478369: 31-311305
• 00887868478352: 31-311304
• 00887868478345: 31-311303
• 00887868478338: 31-311302
• 00887868478321: 31-311301
• 00887868478314: 31-311300
• 00887868478307: 31-311000
• 00887868478079: 31-301890
• 00887868476273: 31-301110
• 00887868476266: 31-301109
• 00887868476259: 31-301107
• 00887868476235: 31-301105
• 00887868476228: 31-301104
• 00887868476211: 31-301103
• 00887868477874: 31-301843
• 00887868477867: 31-301842
• 00887868477850: 31-301841
• 00887868477843: 31-301840
• 00887868477836: 31-301839
• 00887868477829: 31-301838
• 00887868477812: 31-301837
• 00887868477805: 31-301836
• 00887868477799: 31-301835
• 00887868477782: 31-301834