Catalog Number

-

Brand Name

Optimized Positioning System (OPS)

Version/Model Number

1248-1500 and 1248-1700

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

K152893

Product Code

LWJ

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Public Device Record Key

45922bae-44bb-4117-8b1a-51a610c90961

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

April 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-