Catalog Number

CP102838

Brand Name

OSS™ Orthopedic Salvage System

Version/Model Number

CP102838

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

K002757,K123501

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Public Device Record Key

6476f510-d5be-454f-aa42-2250b1b5590d

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-