Catalog Number

20-8020-120-01

Brand Name

ROSA® KNEE OPTICAL UNIT

Version/Model Number

20-8020-120-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K182964

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

337520c4-19a7-4d1b-aa7c-2140a80a564a

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-