SALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Right

GUDID 07640187462500

Bonebridge AG

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID07640187462500
NIH Device Record Key37e812ce-be9c-442a-b6b7-9543252b056b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSALTI 2.5/3.5mm Lateral Distal Fibula Plate, 9 Hole, Right
Version Model NumberB-252120
Company DUNS480244832
Company NameBonebridge AG
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 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
GS107640187462500 [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 Date2025-01-23
Device Publish Date2025-01-15

Devices Manufactured by Bonebridge AG

07640187462364 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 8 Hole, Left2025-01-23
07640187462371 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 8 Hole, Right2025-01-23
07640187462388 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 11 Hole, Left2025-01-23
07640187462395 - SALTI 3.5mm Anterolateral Distal Tibia Plate, 11 Hole, Right2025-01-23
07640187462401 - SALTI 3.5mm Medial Distal Tibia Plate, 8 Hole, Left2025-01-23
07640187462418 - SALTI 3.5mm Medial Distal Tibia Plate, 8 Hole, Right2025-01-23
07640187462425 - SALTI 3.5mm Medial Distal Tibia Plate, 11 Hole, Left2025-01-23
07640187462432 - SALTI 3.5mm Medial Distal Tibia Plate, 11 Hole, Right2025-01-23
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