Duns Number:033467608
Device Description: The BluStone Synergy Obsidian System is implanted using a combination of device specific a The BluStone Synergy Obsidian 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 Obsidian TLIF implant inserter/pusher is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert.
Catalog Number
-
Brand Name
Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)
Version/Model Number
9100-TI01
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
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
c3213c5f-e825-4600-8c0e-96a9d96b3829
Public Version Date
April 23, 2019
Public Version Number
5
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 |