Intramedullary Fixation Scaffold (IFS) - Product received FDA 510(k) clearance for: small - METRIC MEDICAL DEVICES, INC.

Duns Number:830255506

Device Description: Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion

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More Product Details

Catalog Number

2585L3

Brand Name

Intramedullary Fixation Scaffold (IFS)

Version/Model Number

2585L3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

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

-

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

8f1ec761-4ab2-4ef3-a48e-0c859f72d492

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"METRIC MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26