Optimized Ortho Positioning (OPS) System - Pelvic Screw Long - OPTIMIZED ORTHO PTY LTD

Duns Number:745735175

Device Description: Pelvic Screw Long

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Optimized Ortho Positioning (OPS) System

Version/Model Number

1248-0033

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LWJ

Product Code Name

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

Device Record Status

Public Device Record Key

3bb7df8c-f6a2-42e8-9e6d-846f26f96af0

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTIMIZED ORTHO PTY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 55