AnyPlus Spinal Fixation System - The AnyPlus Spinal Fixation System consists of - GS Medical Co., Ltd.

Duns Number:688385418

Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors

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More Product Details

Catalog Number

2711-6555-A0

Brand Name

AnyPlus Spinal Fixation System

Version/Model Number

2711-6555-A0

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

K091717

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

50e63ac6-512d-448c-b0e7-812924a4440d

Public Version Date

January 04, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GS MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 7396