Duns Number:057002266
Device Description: SureMAX-X Cervical Spacer, 7° Lordotic Extra-Large (15mm x 20mm) x 7mm
Catalog Number
1802-07152007
Brand Name
SureMAX-X
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
K193359
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
440610ba-941c-4578-8397-233308423311
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 2020
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 |