Aileron Posterior Fusion System - INTERSPINOUS PUNCH, 4MM - Life Spine, Inc.

Duns Number:183641617

Device Description: INTERSPINOUS PUNCH, 4MM

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More Product Details

Catalog Number

132-1-033

Brand Name

Aileron Posterior Fusion System

Version/Model Number

132-1-033

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

K100407

Product Code Details

Product Code

PEK

Product Code Name

Spinous process plate

Device Record Status

Public Device Record Key

451223f6-90d9-40d1-aca7-4d38841516d4

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 315
2 A medical device with a moderate to high risk that requires special controls. 9180
U Unclassified 47