FDA applicant
Zimmer Spine, Inc.
FDA records 44 decisions for Zimmer Spine, Inc. (Minneapolis, MN) from 1996 to 2016: 43 510(k) clearances and 1 original PMA approval. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 127 predicates, 32 of them its own earlier devices. 18 recalls are linked to its devices.
FDA’s records also spell it “Zimmer Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zimmer Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Zimmer 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.