SImmetry SI Joint Fusion System 10-SL08555-01

GUDID 00810204800036

SImmetry Screw 8.5X55

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device ID00810204800036
NIH Device Record Key06644681-c3e2-4525-8d14-c2cd46a6e8cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSImmetry SI Joint Fusion System
Version Model Number10-SL08555-01
Catalog Number10-SL08555-01
Company DUNS117014636
Company NameTENON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810204800036 [Primary]

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


[00810204800036]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-25
Device Publish Date2025-12-17

On-Brand Devices [SImmetry SI Joint Fusion System ]

00810204802269Guide Pin 3.2MM, Trocar
00810204802252Guide Pin 3.2MM, Trocar
00810204802245Decorticator #3
00810204802238Decorticator #2
00810204802221Decorticator #1
00810204802214Graft Tube, Right Angle
00810204802207Implant Driver
0081020480219122mm Sleeve
0081020480218417mm Sleeve
00810204802177SImmetry Instrument Tray
00810204802160Jacobs Adapter
00810204802153Working Cannula
00810204802146SV01-20447
00810204802139Impactor
008102048021229mm Dilator
0081020480211521mm Dilator
008102048021086mm Drill
00810204802085Implant Remover
00810204802078Graft Press
008102048020619mm Drill
00810204802054Blunt Pin
00810204802047Suction Tube
00810204802030Ratcheting Extended Offset T-Handle
00810204802023Scraper
00810204802016Depth Stop Thumb Screw
00810204800593SImmetry Screw 14.5X110
00810204800586SImmetry Screw 14.5X105
00810204800579SImmetry Screw 14.5X100
00810204800562SImmetry Screw 14.5X95
00810204800555SImmetry Screw 14.5X90
00810204800548SImmetry Screw 14.5X85
00810204800531SImmetry Screw 14.5X80
0081020480052400810204800524
00810204800517SImmetry Screw 14.5X70
00810204800500SImmetry Screw 14.5X65
00810204800494SImmetry Screw 14.5X60
00810204800487SImmetry Screw 14.5X55
00810204800470SImmetry Screw 14.5X50
00810204800463SImmetry Screw 14.5X45
00810204800456SImmetry Screw 14.5X40
00810204800449SImmetry Screw 12.5X110
00810204800432SImmetry Screw 12.5X105
00810204800425SImmetry Screw 12.5X100
00810204800418SImmetry Screw 12.5X95
00810204800401SImmetry Screw 12.5X90
00810204800395SImmetry Screw 12.5X85
00810204800388SImmetry Screw 12.5X80
00810204800371SImmetry Screw 12.5X75
00810204800364SImmetry Screw 12.5X70
00810204800357SImmetry Screw 12.5X65

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