FDA.reportPublic FDA data

FUSIO™ SI Allograft System

Primary DI
00810152101339
Brand
FUSIO™ SI Allograft System
Company
PROMETHEAN RESTORATIVE LLC
Model
CPS0010
Catalog number
CPS0010
Device description
GUIDE TUBE TAP CAP
Published
2025-03-05
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
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
00810152101339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152101339008101521013398101521013390810152101339

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
720-512-5947info@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
00810152100196FUSIO™ SI Allograft SystemBI0019BI00192026-02-13
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
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
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21