Catalog Number

-

Brand Name

SmartLOX Cervical Plate System

Version/Model Number

13340-0011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2022

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

-

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

K141332

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

0baffbb6-a4c9-4396-8543-cf7456777e4b

Public Version Date

September 29, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-