2.5 mm Inion OTPS™ FRF-1023

GUDID 06438408005862

4 hole plate

Inion Oy

Orthopaedic fixation plate, bioabsorbable
Primary Device ID06438408005862
NIH Device Record Key99898e40-b327-47e8-8e65-77aa6423bf53
Commercial Distribution StatusIn Commercial Distribution
Brand Name2.5 mm Inion OTPS™
Version Model Number1
Catalog NumberFRF-1023
Company DUNS367994657
Company NameInion Oy
Device Count1
DM Exemptfalse
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
GS106438408005862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-09-29

On-Brand Devices [2.5 mm Inion OTPS™]

M224FRF104194 hole plate, extended long
M224FRF1036910 hole plate
M224FRF102798 hole plate
M224FRF102696 hole plate, extended
M224FRF102596 hole plate
M224FRF102494 hole plate, extended
M224FRF102394 hole plate
064384080059614 hole plate, extended long
0643840800591610 hole plate
064384080059098 hole plate
064384080058936 hole plate, extended
064384080058866 hole plate
064384080058794 hole plate, extended
064384080058624 hole plate

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