Duns Number:033467608
Device Description: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of de The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The lumbar shavers are available in sizes between 7mm and 15mm.
Catalog Number
-
Brand Name
Blustone Synergy Lumbar Shaver (Basalt, Obsidian, Magma)
Version/Model Number
9001-SH08
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
HTZ
Product Code Name
Instrument, Cutting, Orthopedic
Public Device Record Key
559ed11b-1128-4397-a080-d48e4ff38d23
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 2018
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 | 76 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 64 |