Catalog Number

-

Brand Name

Summa Orthopaedics System Bone Screw

Version/Model Number

SO-40L-SA-048-TA

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

K172008

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

55738d84-d67b-4e78-a852-f002c405a9c2

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

May 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-