FDA.reportPublic FDA data

Blustone Synergy Lumbar Shaver (Basalt, Obsidian, Magma)

Primary DI
00810482030811
Brand
Blustone Synergy Lumbar Shaver (Basalt, Obsidian, Magma)
Company
BLUSTONE SYNERGY, LLC
Model
9001-SH11
Device description
The Blustone Synergy Lumbar Interbody Fusion 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 lumbar shavers are available in sizes between 7mm and 15mm.
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
HTZInstrument, Cutting, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810482030811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482030811008104820308118104820308110810482030811

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width11Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
10603295553625ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553632ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553649ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553656ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
00190376538945Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700885Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700892Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544716General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553670ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
00196449033638Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033669Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033683Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-10
00196449033423Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033430Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033447Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033478Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033485Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033492Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033607Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
00196449033621Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02