WOLF Plate, 278mm, 21 Hole TO-LBP-278

GUDID 00816101012015

The long bone plates are made of titanium alloy, are provided in standard and low profile thicknesses, and also standard and curved configurations. The plates are contoured to provide a close fit with the anatomy of the radius, ulna and humerus bones. The plates are provided with multiple hole configurations and lengths to accommodate fixation cases for a variety of upper extremity diaphyses.

TOBY ORTHOPAEDICS

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00816101012015
NIH Device Record Key4ed23e9b-058d-4da1-b780-261f13348aaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameWOLF Plate, 278mm, 21 Hole
Version Model NumberNA
Catalog NumberTO-LBP-278
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
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
Phone305-665-8699
Emailsales@tobyortho.com
Phone305-665-8699
Emailsales@tobyortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816101012015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

[00816101012015]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-15

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