SIMMETRY+ SI Joint Fusion System

GUDID 00810204801187

SImmetry+ Screw 9.5x65 Sharp Tip

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device ID00810204801187
NIH Device Record Key7b2e959e-7ada-4d3d-9170-70ff126f204b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIMMETRY+ SI Joint Fusion System
Version Model Number10-S08565-01
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
GS100810204801187 [Primary]

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


[00810204801187]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-24
Device Publish Date2025-12-16

On-Brand Devices [SIMMETRY+ SI Joint Fusion System ]

00810204801996Alt Dilator 1.6 Pin
00810204801989Decorticator Body
00810204801972Decorticator Knob
00810204801958Set Screw Driver
00810204801941RETAINING G DRIVER
00810204801934Final Dilator
00810204801927Quick Step Working Cannula
00810204801910Quick Step Drill
00810204801903Quick Step Decorticator Shaft
00810204801897Pin Guide Inserter
00810204801880Pin Guide
00810204801873Final Dilator Handle
00810204801866T handle
008102048018591/4" quick connect Torque limiting Handle
00810204801842Drill 14.5mm Screw
00810204801835Drill 12.5mm Screw
00810204801828Drill 9.5mm Screw
008102048018113.2mm trocar pin short
008102048018043.2mm trocar pin
008102048017983.2mm blunt pin
00810204801781Jacobs Chuck
0081020480177414.5mm Fin Guide
0081020480176712.5mm Fin Guide
008102048017509.5mm Fin Guide
00810204801743Broach 14.5mm Fin
00810204801736Broach 12.5mm Fin
00810204801729Broach 9.5mm Fin
00810204801712Fin Driver
00810204801705Graft Tube
00810204801699Dilator 2
00810204801682Implant Tower
00810204801675Suction Tube
00810204801668Dilator 1
00810204801651Graft Press
00810204801644Impactor
00810204801637Implant Driver
00810204801620SImmetry+ Instrument Tray
00810204801613SImmetry+ Screw 14.5x110 Sharp Tip
00810204801606SImmetry+ Screw 14.5x105 Sharp Tip
00810204801590SIImmetry+ Screw 14.5x100 Sharp Tip
00810204801583SImmetry+ Screw 14.5x95 Sharp Tip
00810204801576SImmetry+ Screw 14.5x90 Sharp Tip
00810204801569SImmetry+ Screw 14.5x85 Sharp Tip
00810204801552SImmetry+ Screw 14.5x80 Sharp Tip
00810204801545SImmetry+ Screw 14.5x75 Sharp Tip
00810204801538SImmetry+ Screw 14.5x70 Sharp Tip
00810204801521SImmetry+ Screw 14.5x65 Sharp Tip
00810204801514SImmetry+ Screw 14.5x60 Sharp Tip
00810204801507SImmetry+ Screw 14.5x55 Sharp Tip
00810204801491SImmetry+ Screw 14.5x50 Sharp Tip

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