Catalog Number

-

Brand Name

SAMBA SCREW SYSTEM

Version/Model Number

11-1109-FD16

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

K121148,K121148

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

0c890b33-6ac4-4aaf-bcd7-52ff8f1225f2

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

September 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-