Orion Headless Screw HTR-04-254714

GUDID M695HTR042547140

Headless Cannulated Screw Short-Thread Ø2.5mm-(L) 14mm

Tyber Medical LLC

Orthopaedic bone screw (non-sliding)
Primary Device IDM695HTR042547140
NIH Device Record Key2abe4520-d7c6-40b8-8f62-9ecc73d748f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrion Headless Screw
Version Model NumberHTR-04-254714
Catalog NumberHTR-04-254714
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
HIBCCM695HTR042547140 [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

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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
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