Catalog Number

INS-1134

Brand Name

Apex

Version/Model Number

INS-1134

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

-

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

K170972

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

5f1ee658-9e1f-43ff-b967-9236fa5d9331

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-