Asfora Anterior Cervical Plate System - 3 Level, 69mm Cervical Plate; The Asfora Anterior - MEDICAL DESIGNS LLC

Duns Number:003815548

Device Description: 3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to pro 3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Asfora Anterior Cervical Plate System

Version/Model Number

11-1106-FD3-69

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K143688,K143688

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

b1c7c95e-90ca-4fe8-9437-014180caf533

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL DESIGNS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 136