Duns Number:146060863
Device Description: Straight Rod, Dual Hex, Size Ø6.0x600 mm, CoCr
Catalog Number
2911-B60600-G1
Brand Name
EVEREST® Spinal System
Version/Model Number
2911-B60600-G1
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
-
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
-
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
a5a437cf-cbd7-4aa1-b273-718dfbfb65c8
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 07, 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 | 5699 |
2 | A medical device with a moderate to high risk that requires special controls. | 17961 |