3.5mm Cortical Screw, 22mm TO-35-CS-22

GUDID 00816101010110

The titanium alloy cortical screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 34mm.

TOBY ORTHOPAEDICS

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 ID00816101010110
NIH Device Record Keya6610b35-60a0-495b-a200-63a2941ac565
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm Cortical Screw, 22mm
Version Model NumberNA
Catalog NumberTO-35-CS-22
Company DUNS024163331
Company NameTOBY ORTHOPAEDICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816101010110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

[00816101010110]

Microwave Radiation

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-09

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