FDA.reportPublic FDA data

Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)

Primary DI
00810482030149
Brand
Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)
Company
BLUSTONE SYNERGY, LLC
Model
1513-C038
Device description
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.
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172330000Blustone Synergy Silica SystemBlustone Synergy2017-12-21MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810482030149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482030149008104820301498104820301490810482030149

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height38Millimeter
Length15Millimeter
Width13Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8002329108admin@blustonesynergy.com

Regulatory Flags#

DUNS number
033467608
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810482030651Blustone Synergy Cervical Inserter 9000-CI012018-01-29
00810482031382Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)9100-TI012018-01-29
00810482031405Blustone Synergy Lumbar PLIF Inserter (Basalt)9200-PI012018-01-29
00810482031429Blustone Synergy Lumbar Lateral Inserter (Magma)9300-LI012018-01-29
00810482030668Blustone Synergy Cervical Pusher 9000-CP012018-01-29
00810482031412Blustone Synergy Lumbar PLIF Pusher (Basalt)9200-PP012018-01-29
00810482030019Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL052018-01-29
00810482030026Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL062018-01-29
00810482030033Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL072018-01-29
00810482030040Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL082018-01-29
00810482030057Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL092018-01-29
00810482030064Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL102018-01-29
00810482030071Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL112018-01-29
00810482030088Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0202018-01-29
00810482030095Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0232018-01-29
00810482030101Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0262018-01-29
00810482030118Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0292018-01-29
00810482030125Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0322018-01-29
00810482030132Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0352018-01-29
00810482030156Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0412018-01-29

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