Chrysalis Intelligence · Sponsors · Spine Wave, Inc.

Spine Wave, Inc.

Shelton, CT, US · 9 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
9
2020-11-05 → 2026-06-15
Last 12 months
2
Product codes
4
Most recent
2026-06-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 4 2025-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 3 2026-05-29
PML Bone Cement, Posterior Screw Augmentation Class II Orthopedic 1 2026-06-15
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2025-04-03
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2026-06-15 K260286 Dynamo™ Spinal Cement; Salvo® Spine System PML Class II Orthopedic
2026-05-29 K261159 Exceed® Biplanar Expandable Interbody System MAX Class II Orthopedic
2025-06-27 K243816 Testa TP Pivoting Spacer System MAX Class II Orthopedic
2025-06-06 K251131 Annex® 2 Adjacent Level System NKB Class II Orthopedic
2025-04-03 K243514 Salvo® Robotic Navigation Instruments OLO Class II Neurology
2024-05-06 K240685 Salvo® Spine System NKB Class II Orthopedic
2023-07-25 K231275 Exceed™ Biplanar Expandable Interbody System MAX Class II Orthopedic
2022-08-29 K222362 Salvo® Spine System NKB Class II Orthopedic
2020-11-05 K202476 Salvo® Spine System NKB Class II Orthopedic
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence