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Data / Medical devices / United States / Janco, Inc.

Janco, Inc.: FDA-registered device maker in Rollinsford, NH, United States, 2 510(k) clearances

Janco, Inc. is registered with the FDA (registration 3010060157) in Rollinsford, NH, United States. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 4, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Janco, Inc.
FDA registration number
3010060157
Address
50 Goodwin Road, Rollinsford, NH, United States, 03869
Owner or operator
Janco, Inc. (10043068)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
January 23, 2013
Registered through
2026
Brand names listed
Bedding, Disposable, Medical- HDS Disposable Pad Kit; HDS Postless Hip Disposables Kit, ClariTEE probe, Fiber-Connect, Force DFX Suture; Force DFX Suture-Xtreme, GFU-100, Insertion Tool, Interference Screw, KinematX and more

Devices it lists

DeviceProduct codeClassRoleSource
Bedding, Disposable, MedicalKME1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufactureraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
PasserHWQ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedJWJ2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Staple, Fixation, BoneJDR2Contract manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Contract manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 4, 2020K191525KinematX Total Wrist Arthroplasty SystemJWJSubstantially EquivalentExtremity Medical, LLCaccessdata.fda.gov
December 14, 2007K073409OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEMGEXSubstantially EquivalentOmniguide, Inc.accessdata.fda.gov

Compare with other makers

Updated March 4, 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.