Inion S-2™ SPN-5401

GUDID M224SPN54019

Plate, 37 x 28 x 3.2 mm

Inion Oy

Spinal fixation plate, bioabsorbable
Primary Device IDM224SPN54019
NIH Device Record Key66d5c621-d6e8-40e0-a5ef-866a43425395
Commercial Distribution Discontinuation2026-10-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameInion S-2™
Version Model Number1
Catalog NumberSPN-5401
Company DUNS367994657
Company NameInion Oy
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
HIBCCM224SPN54019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OJBResorbable spinal intervertebral body fixation orthosis - plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-12-19
Device Publish Date2018-03-26

On-Brand Devices [Inion S-2™]

M224SPN550796.7 x 31 mm screw
M224SPN550696.7 x 28 mm screw
064384080071496.7 x 25 mm screw
064384080071326.7 x 22 mm screw
064384080071256.0 x 31 mm screw
064384080071186.0 x 28 mm screw
064384080071016.0 x 25 mm screw
064384080070956.0 x 22 mm screw
06438408007088Plate, 40 mm (25 mm hole span)
06438408007071Plate, 37 mm (22 mm hole span)
06438408007064Plate, 34 mm (19 mm hole span)
06438408007057Plate, 31 mm (16 mm hole span)
M224SPN5417970 x 35 x 4.5 mm Plate, 6 holes
M224SPN54169120 x 80 x 0.75 mm Plate
06438408007040Plate, 62 x 28 x 3.2 mm
M224SPN54099Plate, 59 x 28 x 3.2 mm
M224SPN54089Plate, 56 x 28 x 3.2 mm
M224SPN54079Plate, 53 x 28 x 3.2 mm
06438408007002Plate, 50 x 28 x 3.2 mm
06438408006999Plate, 49 x 28 x 3.2 mm
06438408006982Plate, 46 x 28 x 3.2 mm
06438408006975Plate, 43 x 28 x 3.2 mm
06438408006968Plate, 40 x 28 x 3.2 mm
06438408006951Plate, 37 x 28 x 3.2 mm
M224SPN550596.7 x 25 mm screw
M224SPN550496.7 x 22 mm screw
M224SPN550396.0 x 31 mm screw
M224SPN550296.0 x 28 mm screw
M224SPN550196.0 x 25 mm screw
M224SPN550096.0 x 22 mm screw
M224SPN54249Plate, 40 mm (25 mm hole span)
M224SPN54239Plate, 37 mm (22 mm hole span)
M224SPN54229Plate, 34 mm (19 mm hole span)
M224SPN54219Plate, 31 mm (16 mm hole span)
M224SPN54109Plate, 62 x 28 x 3.2 mm
M224SPN54069Plate, 50 x 28 x 3.2 mm
M224SPN54059Plate, 49 x 28 x 3.2 mm
M224SPN54049Plate, 46 x 28 x 3.2 mm
M224SPN54039Plate, 43 x 28 x 3.2 mm
M224SPN54029Plate, 40 x 28 x 3.2 mm
M224SPN54019Plate, 37 x 28 x 3.2 mm
0643840801232770 x 35 x 4.5 mm Plate, 6 holes
06438408012310120 x 80 x 0.75 mm Plate
064384080071636.7 x 31 mm screw
064384080071566.7 x 28 mm screw
06438408007033Plate, 59 x 28 x 3.2 mm
06438408007026Plate, 56 x 28 x 3.2 mm
06438408007019Plate, 53 x 28 x 3.2 mm

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