FDA applicant
Premia Spine, Ltd.
FDA records 7 decisions for Premia Spine, Ltd. (Ramat Poleg, Netanya, IL) from 2015 to 2023: 6 510(k) clearances and 1 original PMA approval. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 54 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Premia Spine, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Premia Spine, Ltd.’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