TWIN PEAKS - Lumbar cage for TLIF H8/L30/4° - SPINEWAY

Duns Number:281075270

Device Description: Lumbar cage for TLIF H8/L30/4°

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More Product Details

Catalog Number

TP1T8304

Brand Name

TWIN PEAKS

Version/Model Number

1

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

K152355

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

fa472f84-5bfc-4d1b-b3ad-dcd91da2023b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEWAY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 310
2 A medical device with a moderate to high risk that requires special controls. 196