56-25000

GUDID 34546540373985

Fixation Screws f. Condylar Prosthesis

Stryker Leibinger GmbH & Co. KG

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

Primary Device ID	34546540373985
NIH Device Record Key	7b42c807-3645-4c27-81b0-f4054b89b2e9
Commercial Distribution Status	In Commercial Distribution
Version Model Number	56-25000
Catalog Number	56-25000
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	2
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	4.6 Millimeter
Length	4.6 Millimeter
Length	4.6 Millimeter
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter
Device Size Text, specify	0
Length	4.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540373984 [Unit of Use]
GS1	34546540373985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133285

FDA Product Code

MPL	Mandibular condyle prosthesis
NEI	Prosthesis, condyle, mandibular, temporary