53-20427

GUDID 34546540356148

Lag Screws, Cross-Pin

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

Primary Device ID	34546540356148
NIH Device Record Key	c2ebf822-8282-4f3e-aacd-9748b2f97e9c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	53-20427
Catalog Number	53-20427
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	5
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	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter
Length	2.7 Centimeter
Device Size Text, specify	0
Length	27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540356147 [Unit of Use]
GS1	34546540356148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K014263

FDA Product Code

JEY	PLATE, BONE