FDA applicant
Stryker Spine
FDA records 76 decisions for Stryker Spine (Allendale, NJ) from 1996 to 2026: 75 510(k) clearances and 1 original PMA approval. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MQP (Spinal Vertebral Body Replacement Device). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 364 predicates, 135 of them its own earlier devices. 49 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 Stryker Spine’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Stryker Spine’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 “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.