FDA.reportPublic FDA data

Blustone Synergy Lumbar Interbody Fusion System (Magma)

Primary DI
00810482030620
Brand
Blustone Synergy Lumbar Interbody Fusion System (Magma)
Company
BLUSTONE SYNERGY, LLC
Model
5518-LL12
Device description
The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) 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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171893000Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)Bluestone Synergy2017-09-08MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810482030620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482030620008104820306208104820306200810482030620

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12Millimeter
Length55Millimeter
Width18Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-232-9108admin@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
00810482030149Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0382018-01-29

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Primary DI, Brand, Company table
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