FDA.reportPublic FDA data

Blustone Synergy Lumbar PLIF Pusher (Basalt)

Primary DI
00810482031412
Brand
Blustone Synergy Lumbar PLIF Pusher (Basalt)
Company
BLUSTONE SYNERGY, LLC
Model
9200-PP01
Device description
The BluStone Synergy Basalt 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 Basalt PLIF Pusher is 8.35 inches long.
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXOPusher, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810482031412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482031412008104820314128104820314120810482031412

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length8.35Inch

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
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
00810482030156Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0412018-01-29

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Primary DI, Brand, Company table
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04719878788106“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2025-10-15
04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
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00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
04719878786768“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2024-04-15
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
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