PANTERA PLATE, LEFT, 180mm - The shoulder plates are made of titanium alloy - TOBY ORTHOPAEDICS

Duns Number:024163331

Device Description: The shoulder plates are made of titanium alloy and are designed in right and left configur 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.

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More Product Details

Catalog Number

TO-PHP-L180

Brand Name

PANTERA PLATE, LEFT, 180mm

Version/Model Number

NA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K081608

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

ea9629e5-4447-4373-a358-d5e1ab4c56bb

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOBY ORTHOPAEDICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 41
2 A medical device with a moderate to high risk that requires special controls. 112