Bonebridge AG: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bonebridge AG” (first 2021, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 84 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 369 |
| 2022 | 1 | 266 |
| 2023 | 1 | 76 |
| 2024 | 3 | 79 |
| 2025 | 2 | 116 |
| 2026 | 2 | 76 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bonebridge AG took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 10 | 10 |
Review panels
- Orthopedic (10)
Most recent Bonebridge AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261351 | SALGINA 2.5mm Distal Radius System | HRS | 2026-06-26 | 63 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | HRS | 2026-04-24 | 88 |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | HRS | 2025-12-17 | 156 |
| K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | HRS | 2025-06-11 | 75 |
| K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) | HRS | 2024-12-20 | 60 |
| K242399 | Bonebridge Osteosynthesis Plating System | HRS | 2024-10-31 | 79 |
| K240318 | SITTER 3.5mm Versatile System | HRS | 2024-08-23 | 203 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System | HRS | 2023-07-19 | 76 |
| K213864 | Bonebridge Osteosynthesis Plating System | HRS | 2022-09-02 | 266 |
| K203002 | SALGINA 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 | HRS | 2021-10-05 | 369 |
Recalls
openFDA lists no recalls under a recalling firm named Bonebridge AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bonebridge AG?
FDA lists 10 510(k) clearances under the applicant name “Bonebridge AG” (first 2021, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bonebridge AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bonebridge AG is 84 days. Since 2017: 84 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bonebridge AG?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 10).
Next steps
- See all 10 Bonebridge AG clearances with predicates and recalls
- Run predicate analysis for product code HRS, Bonebridge AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.