Stratum Foot Plating System - STRATUM 1st Metatarsophalangeal Joint (MPJ) - Nextremity Solutions, Inc.

Duns Number:060783407

Device Description: STRATUM 1st Metatarsophalangeal Joint (MPJ) Revision Plate Small - Left

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More Product Details

Catalog Number

-

Brand Name

Stratum Foot Plating System

Version/Model Number

1MPJRVSML

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

-

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

322bd702-c5b9-48bd-b87d-e9c7c281ade2

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

November 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXTREMITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 152
2 A medical device with a moderate to high risk that requires special controls. 560