SMPLE SUBMUSCULAR PLATING SYSTEM 14-448445

GUDID 00888480445821

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00888480445821
• NIH Device Record Key: c349dae2-32a6-4597-b75b-750f56433443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMPLE SUBMUSCULAR PLATING SYSTEM
• Version Model Number: 14-448445
• Catalog Number: 14-448445
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(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 Identifiers

Device Issuing Agency	Device ID
GS1	00888480445821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093983

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SMPLE SUBMUSCULAR PLATING SYSTEM]

• 00880304592315: 14-448805S
• 00880304592285: 14-448800S
• 00880304592278: 14-448800
• 00887868151446: 14-448674
• 00887868151439: 14-448439
• 00887868151422: 14-448434
• 00887868151415: 14-448425
• 00887868151408: 14-448411
• 00887868106873: 14-448675
• 00887868099557: 14-448671
• 00887868099540: 14-448666
• 00887868099533: 14-448661
• 00887868099526: 14-448656
• 00887868099519: 14-448651
• 00887868099441: 14-448466
• 00887868099434: 14-448461
• 00887868099427: 14-448456
• 00887868099410: 14-448451
• 00887868099403: 14-448446
• 00887868099397: 14-448441
• 00887868099380: 14-448437
• 00887868099373: 14-448433
• 00887868099366: 14-448431
• 00887868099359: 14-448429
• 00887868099342: 14-448427
• 00887868099335: 14-448426
• 00887868099328: 14-448423
• 00887868099311: 14-448421
• 00887868099304: 14-448419
• 00887868099298: 14-448417
• 00887868099281: 14-448415
• 00887868099212: 14-448337
• 00887868099205: 14-448333
• 00887868099199: 14-448331
• 00887868099182: 14-448329
• 00887868099175: 14-448327
• 00887868099168: 14-448325
• 00887868099151: 14-448323
• 00887868099144: 14-448321
• 00887868099137: 14-448319
• 00887868099120: 14-448317
• 00887868099113: 14-448315
• 00887868099090: 14-448218
• 00887868099083: 14-448216
• 00887868099076: 14-448214
• 00887868099069: 14-448212
• 00887868099052: 14-448210
• 00887868099038: 14-448118
• 00887868099021: 14-448116
• 00887868099014: 14-448114