Duns Number:057002266
Device Description: SureMAX Cervical Spacer, 14° Hyperlordotic Small (12mm x 14mm) x 9mm
Catalog Number
-
Brand Name
SureMAX
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K182477
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
50be7b5a-db99-444e-a1ad-40e1dd19dbb8
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
February 19, 2019
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 | 212 |
2 | A medical device with a moderate to high risk that requires special controls. | 254 |