PANTERA PLATE, RIGHT, 220mm TO-PHP-R220

GUDID 00816101011018

The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.

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 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00816101011018
NIH Device Record Keyeb8e41bc-d711-466b-9463-c8ef1f1ee1bd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePANTERA PLATE, RIGHT, 220mm
Version Model NumberNA
Catalog NumberTO-PHP-R220
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816101011018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

[00816101011018]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-21
Device Publish Date2020-08-13

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