Catalog Number

PK-SCP3510-TI

Brand Name

Procedure Kit Straight Compression Plate 10 hole with 3.5mm Instruments Ti

Version/Model Number

PK-SCP3510-TI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

7ecd2c64-7b99-43e3-97e9-7df44fd1a3b3

Public Version Date

January 14, 2022

Public Version Number

3

DI Record Publish Date

September 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-