Catalog Number

-

Brand Name

Nextra Hammertoe Correction System

Version/Model Number

NX-GRA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K122031

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

407e7676-f6e2-4359-a881-5a9b51d7dcc6

Public Version Date

September 23, 2022

Public Version Number

7

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-