Catalog Number

-

Brand Name

iASSIST Knee v2 Pod

Version/Model Number

20-8011-501-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 17, 2042

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

K213033

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

6c4cfe28-de1b-4d04-809d-a93575a132bd

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-