FDA applicant
Ortho Kinematics, Inc.
FDA records 6 decisions for Ortho Kinematics, Inc. (Washington, DC) from 2011 to 2017: 6 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 33 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ortho Kinematics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2017
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Ortho Kinematics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Ortho”
FDA records each applicant name separately; these may or may not be the same firm.