54-00650

GUDID 04546540237675

DYNAMIC MESH STD F. 2.0MM SCREWS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

Primary Device ID	04546540237675
NIH Device Record Key	41374b3a-5b6d-497d-bdb9-ea0ed10bc448
Commercial Distribution Status	In Commercial Distribution
Version Model Number	54-00650
Catalog Number	54-00650
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
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	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

Width	90 Millimeter
Width	90 Millimeter
Width	90 Millimeter
Width	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter
Length	9 Centimeter
Width	9 Centimeter
Device Size Text, specify	0
Length	90 Millimeter
Width	90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540237675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983528

FDA Product Code

JEY	PLATE, BONE