Excella II® - Ti 6Al 4V (ELI) - Innovasis, Inc.

Duns Number:156567492

Device Description: Ti 6Al 4V (ELI)

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More Product Details

Catalog Number

SR5580

Brand Name

Excella II®

Version/Model Number

SR5580

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

K102248

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

62816e2c-19c7-49a6-902f-7c0818f65154

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVASIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 252
2 A medical device with a moderate to high risk that requires special controls. 2102