Thorecon Rigid Fixation System— 510(k) K181607
Substantially EquivalentA & E Medical Corporation
FDA 510(k) clearance K181607 for Thorecon Rigid Fixation System, Substantially Equivalent on 2018-10-12. Applicant: A & E Medical Corporation. Device class: 2.
Clearance details
- Applicant
- A & E Medical Corporation
- Product code
- Code JDQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3010
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NJ, US
Recent devices under product code JDQ
view allMore clearances from A & E Medical Corporation
view allAdverse events under product code JDQ
product code JDQ- Death
- 9
- Injury
- 330
- Total
- 339
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 K181607
K-number listed on FDA's recall record- Z-0242-2020 — A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
- Z-0243-2020 — A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
- Z-0244-2020 — A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
- Z-0245-2020 — A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
- Z-0246-2020 — A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.