Catalog Number

-

Brand Name

Trial Neck

Version/Model Number

111-28-0017

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

K181340

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

14d23773-a463-425b-9952-6f6b7d7f3684

Public Version Date

November 04, 2019

Public Version Number

2

DI Record Publish Date

June 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-