Catalog Number

11-9543

Brand Name

Proficient® Posterior Cervical Spine System

Version/Model Number

11-9543

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

-

Product Code

NKG

Product Code Name

Orthosis, Cervical Pedicle Screw Spinal Fixation

Public Device Record Key

3bed84b3-cb45-4da4-a23c-a5dc396739d7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-