OsteoBridge IDSF System— 510(k) K181026
Substantially EquivalentMerete GmbH
FDA 510(k) clearance K181026 for OsteoBridge IDSF System, Substantially Equivalent on 2018-10-17. Applicant: Merete GmbH. Device class: 2.
Clearance details
- Applicant
- Merete GmbH
- Product code
- Product code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Berlin, DE
Recent devices under product code HSB
view allMore clearances from Merete GmbH
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K181026
K-number listed on FDA's recall record- Z-0436-2021 — OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
- Z-0437-2021 — OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
- Z-0438-2021 — OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181026.
Data sourced from openFDA. This site is unofficial and independent of the FDA.