MANZA SCREWS - MANZA TITANIUM CANCELLOUS SCREW 6.5 X 40 MM - STINSON ORTHOPEDICS INC.

Duns Number:080460688

Device Description: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 40 MM

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More Product Details

Catalog Number

104-65-040

Brand Name

MANZA SCREWS

Version/Model Number

104-65-040

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

K121297

Product Code Details

Product Code

LPH

Product Code Name

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

Device Record Status

Public Device Record Key

7f37d879-4a08-4453-a77a-f41d0bb874a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STINSON ORTHOPEDICS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255