Catalog Number

520SL1

Brand Name

Mont Blanc MIS Spinal Systems

Version/Model Number

1

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

-

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

K161387

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

2c361bc3-0a98-4346-88f2-fde1f2af2fda

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-