Catalog Number

O-02-0-557000-0011-300

Brand Name

SurgiCase

Version/Model Number

O-02-0-557000-0011-300

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150780,K150780

Product Code

PLW

Product Code Name

Acetabular Cup Orientation System

Public Device Record Key

9a669207-f3c6-4f48-96cb-cbaa467127a0

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-