Stronghold® C 3D Titanium Interbody Device System - Cervical Titanium Cage - Anatomical 17.5 mm x 14 - Spine Wave, Inc.

Duns Number:067789763

Device Description: Cervical Titanium Cage - Anatomical 17.5 mm x 14 mm x 10 mm

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More Product Details

Catalog Number

SW18125-1410

Brand Name

Stronghold® C 3D Titanium Interbody Device System

Version/Model Number

SW18125-1410

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

K181229

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

caa1f338-2755-4ed6-9563-451a6497300d

Public Version Date

December 14, 2021

Public Version Number

1

DI Record Publish Date

December 06, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINE WAVE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3264