Orion Headless Screw HTR-04-300422

GUDID M695HTR043004220

Headless Cannulated Screw Short-Thread Ø3.0mm-(L) 22mm

Tyber Medical LLC

Orthopaedic bone screw (non-sliding)
Primary Device IDM695HTR043004220
NIH Device Record Key3da233fc-29ed-42c6-b8c8-f0631c2233e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrion Headless Screw
Version Model NumberHTR-04-300422
Catalog NumberHTR-04-300422
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695HTR043004220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-07-25
Device Publish Date2020-02-22

On-Brand Devices [Orion Headless Screw]

M695HTR044547550Headless Cannulated Screw Long-Thread Ø4.5mm-(L) 55mm
M695HTR043010340ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)34mm
M695HTR043009320ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)32mm
M695HTR043008300ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)30mm
M695HTR043007280ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)28mm
M695HTR043006260ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)26mm
M695HTR043005240ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)24mm
M695HTR043004220Headless Cannulated Screw Short-Thread Ø3.0mm-(L) 22mm
M695HTR043003400ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)40mm
M695HTR043002380ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)38mm
M695HTR043001360ORION Ø3.0mm Headless Cannulated Screw, Short Thread, Ti - (L)36mm
M695HTR042549240ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)24mm
M695HTR042548400ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)40mm
M695HTR042547380ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)38mm
M695HTR042547140Headless Cannulated Screw Short-Thread Ø2.5mm-(L) 14mm
M695HTR042546360ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)36mm
M695HTR042545340ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)34mm
M695HTR042544320ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)32mm
M695HTR042543300ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)30mm
M695HTR042542280ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)28mm
M695HTR042541260ORION Ø2.5mm Headless Cannulated Screw, Short Thread, Ti - (L)26mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.