FDA applicant
KLS-Martin L.P.
FDA records 81 decisions for KLS-Martin L.P. (Jacksonville, FL) from 1994 to 2026: 81 510(k) clearances. Most are in product codes JEY (Plate, Bone) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 213 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 206 predicates, 108 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “KLS Martin L.P.”, “Kls Martin GmbH + Co. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided KLS-Martin L.P.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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