ALTO DEVELOPMENT CORP.

FDA Device Registration & Listing · FARMINGDALE, NJ, US · Registration 2242056

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2242056
FEI Number
2242056
Entity Name
ALTO DEVELOPMENT CORP.
City/State/Country
FARMINGDALE, NJ, US
Establishment Address
5206 Asbury Road, FARMINGDALE, NJ 07727, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ALTO DEVELOPMENT CORP. (Owner Number: 2242056)
Owner / Operator Contact Address
5206 Asbury Road, Farmingdale, NJ 07727, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sternalock® XP Rigid Fixation System MYO/Wire® Ultra-Flex Temporary Pacing Wires BI Series Temporary Pacing Wires Instrument Case Rotating Surgical Punch DoubleWire Sternum Sutures Single Wire Sternum Sutures MYO/Wire® Ultra-Thin Temporary Pacing Wires Electrosurgical Cords Sternal Cable System MYO/Wire® Disposable Patient Cables 2 Crimper/Tensioner Wire Twister

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-10-25
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2018-10-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-10-25
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-10-25
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2007-11-07
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2025-03-20
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2008-09-17
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2007-11-07
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2018-09-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-07
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-03-20
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2001-09-18
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-03-20
HXS Twister, Wire Orthopedic Class 1 888.4540 2001-09-18

Official Correspondent

Stephanie Schrauder

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALTO DEVELOPMENT CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242056. Last updated year: 2026. Please use registration number 2242056 when referencing this establishment in official correspondence.
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