Cervical Interbody Spacer - 7mm Cervical PEEK intervertebral body spacer - CALVARY SPINE, LLC

Duns Number:832116532

Device Description: 7mm Cervical PEEK intervertebral body spacer

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

201-07

Brand Name

Cervical Interbody Spacer

Version/Model Number

7mm Large 14mm x 18mm

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

K082260

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

1f64f2b4-5a33-46ca-bf0d-5eca3e981497

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

March 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CALVARY SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 75