FDA.reportPublic FDA data

FUSIO™ SI Allograft System

Primary DI
00810152100462
Brand
FUSIO™ SI Allograft System
Company
PROMETHEAN RESTORATIVE LLC
Model
CPS0017
Catalog number
CPS0017
Device description
"DISTRACTOR, 9"""
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00810152100462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152100462008101521004628101521004620810152100462

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy compression/distraction instrumentA non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable 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
Manufacturing date on label
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
00810152100196FUSIO™ SI Allograft SystemBI0019BI00192026-02-13
00810152100295FUSIO™ SI Allograft SystemBI0020BI00202026-02-13
00810152100332FUSIO™ SI Allograft SystemBI0021BI00212026-02-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31