Inion FreedomScrew™ OSC-3540

GUDID M224OSC35409

Screw 3.5 x 40 mm, cannul.

Inion Oy

Bioabsorbable orthopaedic bone screw
Primary Device IDM224OSC35409
NIH Device Record Key17aba35c-7595-4a92-970a-70fdc2032d85
Commercial Distribution StatusIn Commercial Distribution
Brand NameInion FreedomScrew™
Version Model Number1
Catalog NumberOSC-3540
Company DUNS367994657
Company NameInion Oy
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106438408003523 [Secondary]
HIBCCM224OSC35409 [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 Number4
Public Version Date2023-09-18
Device Publish Date2017-02-07

On-Brand Devices [Inion FreedomScrew™]

M224OSD45559Screw 4.5 x 55 mm (LAG), cannul.
M224OSD45509Screw 4.5 x 50 mm (LAG), cannul.
M224OSD45459Screw 4.5 x 45 mm (LAG), cannul.
M224OSD45409Screw 4.5 x 40 mm (LAG), cannul.
M224OSD45359Screw 4.5 x 35 mm (LAG), cannul.
M224OSD35459Screw 3.5 x 45 mm (LAG), cannul.
M224OSD35409Screw 3.5 x 40 mm (LAG), cannul.
M224OSD35359Screw 3.5 x 35 mm (LAG), cannul.
M224OSD35309Screw 3.5 x 30 mm (LAG), cannul.
M224OSD35259Screw 3.5 x 25 mm (LAG), cannul.
M224OSD35209Screw 3.5 x 20 mm (LAG), cannul.
M224OSC45909Screw 4.5 x 90 mm, cannul.
M224OSC45559Screw 4.5 x 55 mm, cannul.
M224OSC45509Screw 4.5 x 50 mm, cannul.
M224OSC45459Screw 4.5 x 45 mm, cannul.
M224OSC45409Screw 4.5 x 40 mm, cannul.
M224OSC45359Screw 4.5 x 35 mm, cannul.
M224OSC40909Screw 4.0 x 90 mm, cannul.
M224OSC35459Screw 3.5 x 45 mm, cannul.
M224OSC35409Screw 3.5 x 40 mm, cannul.
M224OSC35359Screw 3.5 x 35 mm, cannul.
M224OSC35309Screw 3.5 x 30 mm, cannul.
M224OSC35259Screw 3.5 x 25 mm, cannul.
M224OSC35209Screw 3.5 x 20 mm, cannul.
M224OSB45559Screw 4.5 x 55 mm (LAG)
M224OSB45509Screw 4.5 x 50 mm (LAG)
M224OSB45459Screw 4.5 x 45 mm (LAG)
M224OSB45409Screw 4.5 x 40 mm (LAG)
M224OSB45359Screw 4.5 x 35 mm (LAG)
M224OSB35459Screw 3.5 x 45 mm (LAG)
M224OSB35409Screw 3.5 x 40 mm (LAG)
M224OSB35359Screw 3.5 x 35 mm (LAG)
M224OSB35309PScrew 3.5 x 30 mm (LAG)
M224OSB35259Screw 3.5 x 25 mm (LAG)
M224OSB35209Screw 3.5 x 20 mm (LAG)
M224OSA45909Screw 4.5 x 90 mm
M224OSA45559Screw 4.5 x 55 mm
M224OSA45509Screw 4.5 x 50 mm
M224OSA45459Screw 4.5 x 45 mm
M224OSA45409Screw 4.5 x 40 mm
M224OSA45359Screw 4.5 x 35 mm
M224OSA35459Screw 3.5 x 45 mm
M224OSA35409Screw 3.5 x 40 mm
M224OSA35359Screw 3.5 x 35 mm
M224OSA35309Screw 3.5 x 30 mm
M224OSA35259Screw 3.5 x 25 mm
M224OSA35209Screw 3.5 x 20 mm
M224OSA27409Screw 2.7 x 40 mm
M224OSA27359Screw 2.7 x 35 mm
M224OSA27309Screw 2.7 x 30 mm

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