Catalog Number

PK-EFC0212T

Brand Name

Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti

Version/Model Number

PK-EFC0212T-US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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"

-

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

K182704

Product Code

OBT

Product Code Name

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Public Device Record Key

9e387ff7-3f13-4bea-b315-915de72c29d7

Public Version Date

December 31, 2021

Public Version Number

4

DI Record Publish Date

September 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-