Skip to the page
Get started free

Data / Medical devices / Orthopaedic Surgical Planning And Instrument Guides / United States

FDA-registered makers of Orthopaedic Surgical Planning And Instrument Guides in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Orthopaedic Surgical Planning And Instrument Guides (product code PBF). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 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 of this device in the United StatesWatch these makers
Device
Orthopaedic Surgical Planning And Instrument Guides
Product code
PBF
Country
United States

Makers of Orthopaedic Surgical Planning And Instrument Guides in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Materialise USA, LLC.Plymouth, MI, United StatesContract manufacturer, Manufacturer3January 18, 2017000api.fda.gov
MedCADPlano, TX, United StatesManufacturer3November 4, 2025000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer3November 4, 2025000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer2November 10, 2021000api.fda.gov
Blue Belt Technologies, Inc.Pittsburgh, PA, United StatesManufacturer1June 25, 2025000api.fda.gov
Insight Surgery HoustonHouston, TX, United StatesManufacturer1February 1, 2023000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1March 11, 2020000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer1June 28, 2022000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1March 18, 2024000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1March 18, 2024000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1June 9, 2022000api.fda.gov
Enhatch, IncHasbrouck Heights, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Insight Surgery NebraskaOmaha, NE, United StatesContract manufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
Realized MFGMedina, OH, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov

Updated November 3, 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.