Catalog Number

-

Brand Name

Summa Orthopaedics System Surgical Instrument

Version/Model Number

SO-111-227-R

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

K191972

Product Code

PBF

Product Code Name

Orthopaedic Surgical Planning And Instrument Guides

Public Device Record Key

0ba92686-1c07-4ae6-8d1a-507e791819d6

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-