Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)

GUDID 00810482030125

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.

BLUSTONE SYNERGY, LLC

Vertebral body prosthesis Vertebral body prosthesis
Primary Device ID00810482030125
NIH Device Record Key0c4cf4bf-0fbc-415f-bb8d-69b155359546
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Spinal Intervertebral Body Fixation System (Silica)
Version Model Number1513-C032
Company DUNS033467608
Company NameBLUSTONE SYNERGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002329108
Emailadmin@blustonesynergy.com
Phone8002329108
Emailadmin@blustonesynergy.com

Device Dimensions

Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810482030125]

Moist Heat or Steam Sterilization


[00810482030125]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-01-29

On-Brand Devices [Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)]

00810482030293The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030286The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030279The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030262The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030255The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030248The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030231The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030224The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030217The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030200The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030194The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030187The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030170The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030163The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030156The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030149The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030132The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030125The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030118The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030101The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030095The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
00810482030088The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio

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