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Spine Wave, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories8
Latest FDA decision2026-06-15
TypeNumberDevice NameCodeDateActions
510(k) K260286 Dynamo™ Spinal Cement; Salvo® Spine SystemPML2026-06-15 View
510(k) K261159 Exceed® Biplanar Expandable Interbody SystemMAX2026-05-29 View
510(k) K243816 Testa TP Pivoting Spacer SystemMAX2025-06-27 View
510(k) K251131 Annex® 2 Adjacent Level SystemNKB2025-06-06 View
510(k) K243514 Salvo® Robotic Navigation InstrumentsOLO2025-04-03 View
510(k) K240685 Salvo® Spine SystemNKB2024-05-06 View
510(k) K231275 Exceed™ Biplanar Expandable Interbody SystemMAX2023-07-25 View
510(k) K222362 Salvo® Spine SystemNKB2022-08-29 View
510(k) K202476 Salvo® Spine SystemNKB2020-11-05 View
510(k) K192526 Spine Wave Navigated InstrumentsOLO2019-10-10 View
510(k) K191045 Salvo™ Spine SystemNKB2019-07-10 View
510(k) K182954 Salvo™ Spine SystemNKB2018-12-12 View
510(k) K181596 Spine Wave Navigated InstrumentsOLO2018-10-24 View
510(k) K181440 Proficient® Posterior Cervical Spine SystemNKG2018-07-30 View
510(k) K172594 Proficient® Posterior Cervical Spine SystemNKG2017-12-15 View
510(k) K173175 Paramount Anterior Cervical Cage SystemOVE2017-11-01 View
510(k) K172175 CapSure® PS SystemNKB2017-08-16 View
510(k) K163246 Leva Anterior Expandable Spacer SystemMAX2017-04-06 View
510(k) K162760 Spine Wave Anterior Cervical Spine SystemOVE2017-02-16 View
510(k) K162639 Proficient™ Posterior Cervical Spine SystemNKG2017-02-07 View

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