4.0 x 12mm Screw Super Fastener, ST 340-2012

GUDID 00810074300001

4.0 x 12mm Screw Super Fastener, ST

SMV SCIENTIFIC LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	00810074300001
NIH Device Record Key	38583ae8-238c-4463-a896-3e1c2c5b5bab
Commercial Distribution Status	In Commercial Distribution
Brand Name	4.0 x 12mm Screw Super Fastener, ST
Version Model Number	340-2012
Catalog Number	340-2012
Company DUNS	089645059
Company Name	SMV SCIENTIFIC LLC
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	false
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

Customer Support Contacts

Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com
Phone	1-800-969-0639
Email	quality@osteocentric.com

Device Dimensions

Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter
Outer Diameter	4 Millimeter
Length	12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810074300001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K150981

FDA Product Code

HWC	Screw, Fixation, Bone