56-90656

GUDID 07613327123241

MESH PRE-FORM-CRANIUM-STD-LARGE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327123241
NIH Device Record Key	95c38df9-d9f7-4f1c-97b2-6e5f5ad0655c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90656
Catalog Number	56-90656
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter
Height	26 Millimeter
Length	115 Millimeter
Device Size Text, specify	0
Width	115 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170725

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable