51-17304

GUDID 34546540393983

Bone Screws, Emerg.,Cross-Pin,self-tapp.

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

Primary Device ID	34546540393983
NIH Device Record Key	5d42dd92-e29c-4a46-a714-aa48ee364dcb
Commercial Distribution Status	In Commercial Distribution
Version Model Number	51-17304
Catalog Number	51-17304
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	5
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	true
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

Device Dimensions

Device Size Text, specify	0
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Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0
Length	4 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540393982 [Unit of Use]
GS1	34546540393983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031659

FDA Product Code

JEY	PLATE, BONE