Proficient® Posterior Cervical Spine System - Proficient® Tap, Single Lead 3.1mm, NAV-M - Spine Wave, Inc.

Duns Number:067789763

Device Description: Proficient® Tap, Single Lead 3.1mm, NAV-M

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More Product Details

Catalog Number

10-8564

Brand Name

Proficient® Posterior Cervical Spine System

Version/Model Number

10-8564

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

K181596

Product Code Details

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Device Record Status

Public Device Record Key

f70526ca-97e4-40ad-a158-c45971ef7ab5

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINE WAVE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3264