Ti Cancellous Screw - Ti Cancellous Screw, Ø6.5 x 35mm - UNITED ORTHOPEDIC CORP.

Duns Number:656700556

Device Description: Ti Cancellous Screw, Ø6.5 x 35mm

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


More Product Details

Catalog Number

5206-1035

Brand Name

Ti Cancellous Screw

Version/Model Number

5206-1035

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

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

K122185

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device Record Status

Public Device Record Key

3c4007fc-2b05-4a59-ad8d-29b32d611b3b

Public Version Date

August 07, 2018

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UNITED ORTHOPEDIC CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1150
2 A medical device with a moderate to high risk that requires special controls. 4885