Data / Medical devices / United States / Alto Development Corp.
Alto Development Corp.: FDA-registered device maker in Farmingdale, NJ, United States, 6 510(k) clearances
Alto Development Corp. is registered with the FDA (registration 2242056) in Farmingdale, NJ, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 23, 2020. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2242056
- Address
- 5206 Asbury Road, Farmingdale, NJ, United States, 07727
- Owner or operator
- ALTO DEVELOPMENT CORP. (2242056)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- September 18, 2001
- Registered through
- 2026
- Brand names listed
- BI Series Temporary Pacing Wires, Cable Cutter, Crimper/Tensioner, DoubleWire Sternum Sutures, Electrosurgical Cords, Instrument Case, MYO/Wire® Disposable Patient Cables 2, MYO/Wire® Ultra-Flex Temporary Pacing Wires and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Cerclage, Fixation | JDQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Pacemaker, Temporary | LDF | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable | GAO | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2020 | K193479 | Sternal Cable System | JDQ | Substantially Equivalent | A & E Medical Corporation | accessdata.fda.gov |
| October 12, 2018 | K181607 | Thorecon Rigid Fixation System | JDQ | Substantially Equivalent | A & E Medical Corporation | accessdata.fda.gov |
| July 12, 2004 | K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | LDF | Substantially Equivalent | European Custom Manufacturing BV | accessdata.fda.gov |
| January 7, 1994 | K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | GAO | Substantially Equivalent | Alto Development Corp. | accessdata.fda.gov |
| May 17, 1993 | K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | GEI | Substantially Equivalent | Alto Development Corp. | accessdata.fda.gov |
| July 1, 1981 | K803086 | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE | LDF | Substantially Equivalent | Craig & Craig, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 10, 2019 | 83942 | Class II | Terminated | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum. | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable. | accessdata.fda.gov |
| June 21, 2019 | 83285 | Class II | Terminated | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) MYO/Wire Ultra-Flex Monopolar (Org.,2 | Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop. | accessdata.fda.gov |
| October 23, 2017 | 79274 | Class II | Terminated | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures. | Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility. | accessdata.fda.gov |
| April 18, 2011 | 60942 | Not yet classified | Terminated | Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Pac | The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Pacemaker, Temporary
- All makers of Cable, Electrode
- All makers of Suture, Nonabsorbable
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Instrument, Cutting, Orthopedic
- All makers of Tray, Surgical
Updated March 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.