FDA applicant
K2m, Inc.
FDA records 127 decisions for K2m, Inc. (Leesburg, VA) from 2005 to 2026: 127 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 548 predicates, 315 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “K2m”, “K2m, LLC”, “K2m, Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided K2m, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like K2m, 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) Report