Aurora Spine - ZIP BONE TAMP - AURORA SPINE, INC.

Duns Number:079119091

Device Description: ZIP BONE TAMP

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More Product Details

Catalog Number

001-026

Brand Name

Aurora Spine

Version/Model Number

ZIP

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

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

e7287a5f-a0a2-4105-ab86-6505e3ac11a5

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

June 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AURORA SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 119
2 A medical device with a moderate to high risk that requires special controls. 2430