510(k) K243308
- Device
- Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- Applicant
- Bonebridge AG
- 510(k) number
- K243308
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-20
- Date received
- 2024-10-21
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michelle Gumpelmayer
- Address
- Bahnhofstrasse 11 Zug CH 6300 6300
FDA Registration Numbers#
- 3016778139
- 3038776593
- 3004142400
- 3016050940
- 3004983210
- 3011127597
- 3006395932
- 2242056
- 3001239363
- 3008868758
- 9611281
- 3015869121
- 3010509633
- 3014763043
- 9611813
- 1423662
- 3010009693
- 9613350
- 3003541440
- 3019455
- 3009662565
- 3017980266
- 3009882675
- 3008749819
- 3005004799
- 3009996260
- 3009381600
- 3008559295
- 2244478
- 9680825
- 3012329552
- 1000517406
- 3013055499
- 3014315669
- 8010944
- 3029933740
- 3010123172
- 3014273424
- 3011388423
- 3015877656
- 1032347
- 3010158639
- 3026576110
- 3014967149
- 3007791110
- 3014967969
- 9710629
- 3016851379
- 3009826895
- 3031240334
- 3002993234
- 9710312
- 3009973699
- 3004049923
- 3023808054
- 3006946279
- 3010041511
- 3010363503
- 3017435639
- 3014004349
- 3019807891
- 3016655171
- 3010470577
- 1424434
- 1528646
- 3014655115
- 3005983700
- 3033519208
- 3020584246
- 3002808145
- 3030926959
- 3015399803
- 1834331
- 2249529
- 3015131017
- 3003761012
- 2030624
- 3021336182
- 3017521423
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | 2026-07-16 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | 2026-06-16 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 |