92-04006

GUDID 07613327503340

3D ORBITAL FLOOR PLATE, LEFT, SMALL

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	07613327503340
NIH Device Record Key	0b271369-1fba-44dc-bb78-fe02d194eba8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-04006
Catalog Number	92-04006
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

Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter
Width	34 Millimeter
Length	31 Millimeter
Device Size Text, specify	0
Height	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327503340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133461

FDA Product Code

JEY	PLATE, BONE