FS3 Facet Screw Spinal System - FS3 Dilation Tube, #4, with Teeth - Life Spine, Inc.

Duns Number:183641617

Device Description: FS3 Dilation Tube, #4, with Teeth

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More Product Details

Catalog Number

2017-0001

Brand Name

FS3 Facet Screw Spinal System

Version/Model Number

2017-0001

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

-

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

K090865

Product Code Details

Product Code

MRW

Product Code Name

SYSTEM, FACET SCREW SPINAL DEVICE

Device Record Status

Public Device Record Key

c718b64f-461e-4b89-9854-0ec39eef7f40

Public Version Date

November 15, 2019

Public Version Number

1

DI Record Publish Date

November 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 315
2 A medical device with a moderate to high risk that requires special controls. 9180
U Unclassified 47