Catalog Number

IMP-WC-0705

Brand Name

Implate

Version/Model Number

IMPLATE Connector, 7mm x 5°

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

K092720

Product Code

HSP

Product Code Name

SPLINT, TRACTION

Public Device Record Key

ad7e5733-e09d-4639-b571-c6e43b466ae9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-