N-Force 7.3 Fixation System - N-Force 7.3 Fixation System 120mm Non-Fenestrated - Innovision, Inc

Duns Number:942243767

Device Description: N-Force 7.3 Fixation System 120mm Non-Fenestrated Screw & Washer Assembly

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More Product Details

Catalog Number

IN038-120-FS

Brand Name

N-Force 7.3 Fixation System

Version/Model Number

IN038-120-FS

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

K132244,K151146

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

e5f15094-b7be-4b8f-b10d-2e2c55e7a120

Public Version Date

July 06, 2018

Public Version Number

5

DI Record Publish Date

February 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVISION, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 55