Duns Number:832116532
Device Description: 7mm Cervical PEEK intervertebral body spacer
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
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |