Catalog Number

-

Brand Name

Optimized Ortho Positioning (OPS) System

Version/Model Number

1248-0035

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

K152893

Product Code

LWJ

Product Code Name

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

Public Device Record Key

dafb805d-e136-4dab-9590-6e649551e814

Public Version Date

February 19, 2020

Public Version Number

1

DI Record Publish Date

February 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-