REVOLVE - 5.5mm REVOLVE Rod, CoCr, 140mm - GLOBUS MEDICAL, INC.

Duns Number:139105691

Device Description: 5.5mm REVOLVE Rod, CoCr, 140mm

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More Product Details

Catalog Number

-

Brand Name

REVOLVE

Version/Model Number

785.340

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111449

Product Code Details

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Record Status

Public Device Record Key

da007738-86d2-421c-9a6b-32843042d335

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 28, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4975
2 A medical device with a moderate to high risk that requires special controls. 34645
3 A medical device with high risk that requires premarket approval 57
U Unclassified 232