FDA.reportPublic FDA data

Blustone Synergy Lumbar Lateral Inserter (Magma)

Primary DI
00810482031429
Brand
Blustone Synergy Lumbar Lateral Inserter (Magma)
Company
BLUSTONE SYNERGY, LLC
Model
9300-LI01
Device description
The Blustone Synergy Magma 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 Magma lateral implant inserter is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly, cleaning and sterilization of the inserter instrument are provided in the product insert.
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810482031429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482031429008104820314298104820314290810482031429

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.48Inch
Lumen/Inner Diameter0.18Inch

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17