neoWave C - neoWave Cervical Cage, Domed, 15W x 12D x 7H, 7deg - HT MEDICAL, LLC

Duns Number:080386764

Device Description: neoWave Cervical Cage, Domed, 15W x 12D x 7H, 7deg

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More Product Details

Catalog Number

N/A

Brand Name

neoWave C

Version/Model Number

20-CAT-5207

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

K180401

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

3c90e750-6b34-4ea9-a825-02fb1176b120

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 178
2 A medical device with a moderate to high risk that requires special controls. 414