AUTO PILOT 52-91766

GUDID 37613327283601

BONE SCREWS, CROSS-PIN, AUTO-PILOT

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, 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	37613327283601
NIH Device Record Key	a30f5e71-e69d-4eb9-813c-28c10e225864
Commercial Distribution Status	In Commercial Distribution
Brand Name	AUTO PILOT
Version Model Number	52-91766
Catalog Number	52-91766
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

Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter
Device Size Text, specify	0
Length	6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327283600 [Unit of Use]
GS1	37613327283601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K970912

FDA Product Code

HWC	Screw, fixation, bone