Fracture and Correction CoLag™ 2 - COLAG 2 SCREW, Ø4.0X57.5 - IN2BONES USA, LLC

Duns Number:079700711

Device Description: COLAG 2 SCREW, Ø4.0X57.5

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More Product Details

Catalog Number

-

Brand Name

Fracture and Correction CoLag™ 2

Version/Model Number

P68 ST157

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

K180377

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

08e0a781-281d-42c8-9b08-98785dc87cca

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES USA, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113
2 A medical device with a moderate to high risk that requires special controls. 1255