56-90322S

GUDID 07613327382457

1.2MM DYNAMIC MESH-MALL-SMALL-S

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	07613327382457
NIH Device Record Key	fb83c587-9678-4726-9edb-d44d922f2b04
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-90322S
Catalog Number	56-90322S
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	true
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

Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Width	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327382457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182425

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-12-20
Device Publish Date	2018-11-19

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

07613327634952 - NA	2024-12-16 Drill for 6514-7-200 WL 16mm
07613327634969 - NA	2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634976 - NA	2024-12-16 Drill for 6514-7-200 WL 10mm
07613327634983 - NA	2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634990 - NA	2024-12-16 Drill for 6514-7-200 14mm
07613327635003 - NA	2024-12-16 Drill for 6514-7-200 WL 10mm
07613327635010 - NA	2024-12-16 Drill for 6514-7-200 WL 14mm
07613327651058 - NA	2024-11-20 T-plate malleable left

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