OsseoScrew - Cannulated Anti-torque Standard/Hightop - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: Cannulated Anti-torque Standard/Hightop

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More Product Details

Catalog Number

-

Brand Name

OsseoScrew

Version/Model Number

62922-HT

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

-

Product Code Details

Product Code

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

c5eb97a2-bd35-4f52-aab4-e55f051a7048

Public Version Date

January 07, 2020

Public Version Number

1

DI Record Publish Date

December 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHATEC SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5644
2 A medical device with a moderate to high risk that requires special controls. 26570
U Unclassified 15