Duns Number:033467608
Device Description: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configur The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The implants are designed with a 15mm x 13mm footprint in heights ranging from 20 to 50mm in three (3) mm increments. The device is hollow to allow for placement of autograft and/or allogenic bone graft and facilitate fusion, and contains tantalum markers to assist the surgeon with proper placement of the device. The device may be implanted as a single device via an anterior approach.
Catalog Number
-
Brand Name
Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)
Version/Model Number
1513-C026
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
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
K172330
Product Code
MQP
Product Code Name
Spinal Vertebral Body Replacement Device
Public Device Record Key
4ed3b269-71df-4018-88da-0a245045ed6e
Public Version Date
February 24, 2020
Public Version Number
4
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 |