FDA.reportPublic FDA data

FUSIO™ SI Allograft System

Primary DI
00810152100196
Brand
FUSIO™ SI Allograft System
Company
PROMETHEAN RESTORATIVE LLC
Model
BI0019
Catalog number
BI0019
Device description
Guidewire, DIA 3.2mm X 340mm
Published
2026-02-13
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152100196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152100196008101521001968101521001960810152100196

GMDN Terms#

Term, Definition table
TermDefinition
Spinal guidewireA thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
720-512-5947info-PR@prometheanrestorative.com

Regulatory Flags#

DUNS number
124592779
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152103203DYNAMIS™ Implant SystemSI0012SI00122026-03-03
00810152104118DYNAMIS™ Implant SystemSI0010SI00102026-03-03
00810152100011FUSIO™ SI Allograft SystemBI0001BI00012026-02-13
00810152100158FUSIO™ SI Allograft SystemBI0015BI00152026-02-13
00810152100295FUSIO™ SI Allograft SystemBI0020BI00202026-02-13
00810152100332FUSIO™ SI Allograft SystemBI0021BI00212026-02-13
00810152100462FUSIO™ SI Allograft SystemCPS0017CPS00172026-02-13
00810152101391FUSIO™ SI Allograft SystemCPS0013CPS00132026-02-13
00810152102039FUSIO™ SI Allograft SystemCPS0016CPS00162026-02-13
00810152100004FUSIO SI Allograft SystemBI0001BI00012024-10-18
00810152101285FUSIO™ SI Allograft SystemCPS0005CPS00052025-03-05
00810152101339FUSIO™ SI Allograft SystemCPS0010CPS00102025-03-05
00810152100097FUSIO SI Allograft SystemBI0009BI00092024-10-18
00810152100516DYNAMIS™ Navigation SystemSI0220SI02202026-01-20
00810152100646DYNAMIS™ Navigation SystemSI0201SI02012026-01-20
00810152100653DYNAMIS™ Navigation SystemSI0202SI02022026-01-20
00810152100677DYNAMIS™ Navigation SystemSI0203SI02032026-01-20
00810152100684DYNAMIS™ Navigation SystemSI0204SI02042026-01-20
00810152100721DYNAMIS™ Navigation SystemSI0205SI02052026-01-20
00810152100738DYNAMIS™ Navigation SystemSI0206SI02062026-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03