Catalog Number

PA 3534-10-2

Brand Name

LOQTEQ®

Version/Model Number

PA 3534-10-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K161747

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

e460c5f8-0c47-4e02-acf6-ccdf2e7ff3c7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-