FDA applicant
Globus Medical, Inc.
FDA records 176 decisions for Globus Medical, Inc. (Audubon, PA) from 2003 to 2026: 175 510(k) clearances and 1 original PMA approval. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 790 predicates, 468 of them its own earlier devices. 29 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Globus Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
5in 2023
Class I Class II/III not classified
Planning a device like Globus Medical, 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 “Globus”
FDA records each applicant name separately; these may or may not be the same firm.