Catalog Number

-

Brand Name

CosmoLock Pedicle Screw System

Version/Model Number

10-SBN-0450

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

012ab086-f73a-423a-aa37-4ae349187942

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-