92-54345

GUDID 07613154556625

DYNAMIC MESH FOR 1.7/1.9MM 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	07613154556625
NIH Device Record Key	bef1bdd8-89cc-4a9d-901f-4c530f674c8e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-54345
Catalog Number	92-54345
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	120 Millimeter
Width	120 Millimeter
Width	120 Millimeter
Width	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter
Length	12 Centimeter
Device Size Text, specify	0
Width	12 Centimeter
Length	120 Millimeter
Width	120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154556625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983528

FDA Product Code

JEY	PLATE, BONE