Fibula Plate 3.5mm 21226-12

GUDID 09120047298343

Fibula Plate 3.5mm, 12-Hole, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120047298343
NIH Device Record Keyeed7cc52-4017-47b9-8bec-ab922f09981d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibula Plate 3.5mm
Version Model Number21226-12
Catalog Number21226-12
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120047298343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


[09120047298343]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-08

On-Brand Devices [Fibula Plate 3.5mm]

09120047298350Fibula Plate 3.5mm, 12-Hole, Right
09120047298343Fibula Plate 3.5mm, 12-Hole, Left
09120047298336Fibula Plate 3.5mm, 10-Hole, Left
09120047298329Fibula Plate 3.5mm, 10-Hole, Right
09120047298312Fibula Plate 3.5mm, 8-Hole, Left
09120047298305Fibula Plate 3.5mm, 8-Hole, Right
09120047298299Fibula Plate 3.5mm, 6-Hole, Left
09120047298282Fibula Plate 3.5mm, 6-Hole, Right
09120047298275Fibula Plate 3.5mm, 4-Hole, Left
09120047298268Fibula Plate 3.5mm, 4-Hole, Right

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.