ORTHOLOC 3DSi

GUDID 00840420110206

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00840420110206
NIH Device Record Key	0cba1810-20fa-43f2-921b-8f515ebec153
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORTHOLOC 3DSi
Version Model Number	40223534
Company DUNS	807201207
Company Name	WRIGHT MEDICAL TECHNOLOGY, INC.
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com
Phone	+1(800)238-7117
Email	customerservice@wmt.com

Device Dimensions

Length	34 Millimeter
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0
Outer Diameter	3.5 Millimeter
Length	34 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420110206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113014

FDA Product Code

HWC	Screw, fixation, bone