WishBone Plate & Screw System - Superior Mid-Shaft Narrow Straight Clavicle Plate - WISHBONE MEDICAL, INC.

Duns Number:062355158

Device Description: Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit, 8 hole, Left with 3.5mm I Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit, 8 hole, Left with 3.5mm Instruments, Ti

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More Product Details

Catalog Number

-

Brand Name

WishBone Plate & Screw System

Version/Model Number

PK-SMC0835NSL-TI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180736

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

2ae63a99-cbe8-40c4-86bf-80008a2122d5

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WISHBONE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 142
2 A medical device with a moderate to high risk that requires special controls. 1453