Bonebridge Osteosynthesis Plating System
K-Number: K213864 · 2022-09-02
ApplicantBonebridge AG
Decision Date2022-09-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Bonebridge Osteosynthesis Plating System is a medical device manufactured by Bonebridge AG. It received FDA 510(k) clearance on 2022-09-02 under approval number K213864. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bonebridge Osteosynthesis Plating System?
Bonebridge Osteosynthesis Plating System is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Bonebridge AG. The 510(k) number is K213864.
When was Bonebridge Osteosynthesis Plating System approved by the FDA?
Bonebridge Osteosynthesis Plating System received FDA 510(k) clearance on 2022-09-02, under approval number K213864.
What company makes Bonebridge Osteosynthesis Plating System?
Bonebridge Osteosynthesis Plating System is manufactured by Bonebridge AG.
What is the FDA product code for Bonebridge Osteosynthesis Plating System?
The FDA product code for Bonebridge Osteosynthesis Plating System is HRS.
Other Devices by Bonebridge AG
K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
K242399Bonebridge Osteosynthesis Plating System
K240318SITTER 3.5mm Versatile System
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.