MULTIDIRECTIONAL SCREW 816335095

GUDID 00887868046902

Biomet Orthopedics, LLC

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

Primary Device ID	00887868046902
NIH Device Record Key	bd5e5888-1954-409b-a11b-0e262d0fbdbd
Commercial Distribution Status	In Commercial Distribution
Brand Name	MULTIDIRECTIONAL SCREW
Version Model Number	8163-35-095
Catalog Number	816335095
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	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
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

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Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868046902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090877

FDA Product Code

LXT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE