BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40— 510(k) K123081
Substantially EquivalentAap Biomaterials GmbH & Co. KG
FDA 510(k) clearance K123081 for BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40, Substantially Equivalent on 2013-03-07. Applicant: Aap Biomaterials GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Aap Biomaterials GmbH & Co. KG
- Product code
- Code LOD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Dieburg, DE
Recent devices under product code LOD
view allMore clearances from Aap Biomaterials GmbH & Co. KG
view allAdverse events under product code LOD
product code LOD- Death
- 44
- Injury
- 3,004
- Malfunction
- 895
- Other
- 4
- Total
- 3,947
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 K123081
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123081.
Data sourced from openFDA. This site is unofficial and independent of the FDA.