FuseFix Hammertoe M13-S20013-S

GUDID M695M13S20013S0

FuseFix Solid 0° Ø2.0mm x 13mm

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDM695M13S20013S0
NIH Device Record Key4edfd300-84d2-4ea9-8206-758f755f6747
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuseFix Hammertoe
Version Model NumberM13-S20013-S
Catalog NumberM13-S20013-S
Company DUNS010968002
Company NameTyber Medical LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695M13S20013S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-01-17
Device Publish Date2019-08-23

On-Brand Devices [FuseFix Hammertoe]

M695M1901011S0Mini Fixed AO Handle w/ Ø1.1mm Guidewire (6”) Kit
M695M1901009S0Mini Fixed AO Handle w/ Ø0.9mm Guidewire (6”) Kit
M695M1901000S0Mini Fixed AO Handle
M695M13S30115S0FuseFix Solid 10° Ø3.0mm x 15mm
M695M13S30015S0FuseFix Solid 0° Ø3.0mm x 15mm
M695M13S25115S0FuseFix Solid 10° Ø2.5mm x 15mm
M695M13S25115D0Demo FuseFix Solid 10° Ø2.5mm x 15mm
M695M13S25015S0FuseFix Solid 0° Ø2.5mm x 15mm
M695M13S25015D0Demo FuseFix Solid 0° Ø2.5mm x 15mm
M695M13S20113S0FuseFix Solid 10° Ø2.0mm x 13mm
M695M13S20013S0FuseFix Solid 0° Ø2.0mm x 13mm
M695M13C30015S0FuseFix Cannulated Ø3.0mm x 15mm
M695M13C25015S0FuseFix Cannulated Ø2.5mm x 15mm
M695M13C25015D0Demo FuseFix Cannulated Ø2.5mm x 15mm
M695M13C20013S0FuseFix Cannulated Ø2.0mm x 13mm

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