Hip Side Plate 130 Deg 6 Hole - Hip Side Plate 130 Degree 6 Hole - SMV SCIENTIFIC LLC

Duns Number:089645059

Device Description: Hip Side Plate 130 Degree 6 Hole

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More Product Details

Catalog Number

317-31306

Brand Name

Hip Side Plate 130 Deg 6 Hole

Version/Model Number

317-31306

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

K210247

Product Code Details

Product Code

KTT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Device Record Status

Public Device Record Key

5a503764-77c4-4f5a-a5d4-62002134f8ba

Public Version Date

May 17, 2021

Public Version Number

1

DI Record Publish Date

May 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMV SCIENTIFIC LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 60
2 A medical device with a moderate to high risk that requires special controls. 846