Proficient® Posterior Cervical Spine System - Curved Bulleted Rod, Ti, 3.5 mm x 60 mm - Spine Wave, Inc.

Duns Number:067789763

Device Description: Curved Bulleted Rod, Ti, 3.5 mm x 60 mm

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More Product Details

Catalog Number

-

Brand Name

Proficient® Posterior Cervical Spine System

Version/Model Number

21-9126

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181440

Product Code Details

Product Code

NKG

Product Code Name

Orthosis, Cervical Pedicle Screw Spinal Fixation

Device Record Status

Public Device Record Key

dd006e11-460b-452e-89a4-7f20c2c49ed7

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

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