Headless Screw System 401-25218

GUDID M695401252180

Ø2.5 x 18mm Short Thread Ti (Torx)

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDM695401252180
NIH Device Record Keyf3035973-b824-41ca-bbde-0d129d51122f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeadless Screw System
Version Model Number401-25218
Catalog Number401-25218
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 Datefalse
Expiration Datefalse
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
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695401252180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


[M695401252180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-13
Device Publish Date2020-01-03

On-Brand Devices [Headless Screw System]

M695401252220Ø2.5 x 22mm Short Thread Ti (Torx)
M695401252200Ø2.5 x 20mm Short Thread Ti (Torx)
M695401252180Ø2.5 x 18mm Short Thread Ti (Torx)
M695401252160Ø2.5 x 16mm Short Thread Ti (Torx)
M695401252140Ø2.5 x 14mm Short Thread Ti (Torx)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.