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Data / Medical devices / Driver, Wire, And Bone Drill, Manual / United States

FDA-registered makers of Driver, Wire, And Bone Drill, Manual in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Driver, Wire, And Bone Drill, Manual (product code DZJ). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.

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Device
Driver, Wire, And Bone Drill, Manual
Product code
DZJ
Country
United States

Makers of Driver, Wire, And Bone Drill, Manual in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer4April 26, 2021010api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer2December 11, 2024000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer2March 11, 2019000api.fda.gov
MedCADPlano, TX, United StatesManufacturer2March 7, 2023000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer2April 1, 2004000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer2March 7, 2023000api.fda.gov
ImmersiveTouch, Inc.Chicago, IL, United StatesManufacturer1June 9, 2020000api.fda.gov
Insight Surgery HoustonHouston, TX, United StatesManufacturer1September 30, 2022000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer1February 21, 2025000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesManufacturer1June 21, 2021000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1June 23, 2015000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Insight Surgery NebraskaOmaha, NE, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov

Updated November 2, 2026. 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.