FDA applicant
Zimmer Biomet Spine, Inc.
FDA records 15 decisions for Zimmer Biomet Spine, Inc. (Westminister, CO) from 2017 to 2021: 15 510(k) clearances. 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 79 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 2 of them its own earlier devices. 25 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zimmer Biomet Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2021
2026 so far, outlined.
Recalls per year
23in 2020
Class I Class II/III not classified
Planning a device like Zimmer Biomet Spine, 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 “Zimmer”
FDA records each applicant name separately; these may or may not be the same firm.