Insignia - Insignia, ACP, 1 Level, 30mm - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: Insignia, ACP, 1 Level, 30mm

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More Product Details

Catalog Number

-

Brand Name

Insignia

Version/Model Number

336-0130

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

K213443

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Device Record Status

Public Device Record Key

cd6749a3-48f6-48e8-9817-f5d3bf02d55d

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

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