56-91064

GUDID 07613327123289

MESH PRE-FORM-LATERAL-STIFF-L

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	07613327123289
NIH Device Record Key	af6b31c8-0040-4131-a259-fe96d49958d7
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-91064
Catalog Number	56-91064
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	8 Centimeter
Height	8 Centimeter
Height	8 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter
Width	12 Centimeter
Device Size Text, specify	0
Length	17.5 Centimeter
Height	8 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170725

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable