Alto Development Corp
FDA Regulatory Profile
Alto Development Corp appears in FDA public data with 7 recalls, 10 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0243-2020, Class II) was initiated on September 10, 2019. Its most recent 510(k) clearance was granted on December 20, 1996.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 10
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0243-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstru | September 10, 2019 |
| Z-0242-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruct | September 10, 2019 |
| Z-0244-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruct | September 10, 2019 |
| Z-0245-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstru | September 10, 2019 |
| Z-0246-2020 | Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruct | September 10, 2019 |
| Z-2098-2019 | Class II | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES | June 21, 2019 |
| Z-0813-2018 | Class II | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to | October 23, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON | December 20, 1996 |
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | January 7, 1994 |
| K931537 | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT | September 7, 1993 |
| K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | May 17, 1993 |
| K914193 | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT | October 5, 1992 |
| K915300 | A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES | February 18, 1992 |
| K884783 | RANEY CLIP | November 30, 1988 |
| K881413 | ELECTRO-CAUTERY SUCTION TUBE | April 21, 1988 |
| K831867 | PRESSURE MONITORING IV BOTTLE CAP | August 12, 1983 |
| K821518 | MYO/CLIP | July 8, 1982 |