SiLO TFX MIS Sacroiliac Joint Fixation System

GUDID B52111400445200

SiLO TFX Sacrum Screw Ø4.5mm x 20mm

AURORA SPINE, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device IDB52111400445200
NIH Device Record Key53de36fc-96b4-4808-9dfa-03aa0959263a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSiLO TFX MIS Sacroiliac Joint Fixation System
Version Model Number114-004-4520
Company DUNS079119091
Company NameAURORA SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us
Phone760.424.2004
Emailinfo@auroraspine.us

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB52111400445200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

[B52111400445200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-21
Device Publish Date2024-08-13

On-Brand Devices [SiLO TFX MIS Sacroiliac Joint Fixation System]

B521114600030SiLO TFX Caddy, Drop-In
B521114600020SiLO TFX™ Caddy, Lid
B521114600010SiLO TFX Caddy, Block
B5211143150SiLO TFX Flex Retaining Driver
B521114310030SiLO TFX™ Hexalobular Adapter
B521114310020SiLO TFX Square Adapter
B521114310010SiLO TFX Inserter Adapter
B5211143090SiLO TFX Ghost Tube
B52111430301240SiLO TFX Decorticating Reamer 24mm
B521114301010SiLO TFX Inserter
B521114300010SiLO TFX Joint Finder
B52111400445260SiLO TFX Ilium Screw Ø4.5mm x 26mm
B52111400445200SiLO TFX Sacrum Screw Ø4.5mm x 20mm
B521114001240SiLO TFX Transfixing Bridge 24mm
B5211107120Removable Handle
B52111036420Guidepin Ø2.4mm x 280mm Smooth Sharp
B52111036110Mallet 1lb 2oz
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