92-00647

GUDID 04546540685049

MESH PRE-FORMED F. 1.7/1.9MM SCREWS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	04546540685049
NIH Device Record Key	ff3eb5ae-6aed-438b-a759-1089ff8be206
Commercial Distribution Status	In Commercial Distribution
Version Model Number	92-00647
Catalog Number	92-00647
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

Length	190 Millimeter
Length	190 Millimeter
Length	190 Millimeter
Length	190 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter
Length	19 Centimeter
Width	14 Centimeter
Device Size Text, specify	0
Width	140 Millimeter
Length	190 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540685049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983528

FDA Product Code

JEY	PLATE, BONE