92-90614

GUDID 07613327459500

DYNAMIC MESH-STD-ARC

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 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 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	07613327459500
NIH Device Record Key	dfbe32d6-35e3-4284-bcef-1db53c032e81
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-90614
Catalog Number	92-90614
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	false
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

Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter
Length	84 Millimeter
Device Size Text, specify	0
Width	31 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327459500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K031659
Premarket Notification: K161821

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable