FDA 510(k)

Dynamo™脊椎水泥；Salvo®脊椎系統

K 號：K260286 · 2026-06-15

決定日期2026-06-15

產品代碼PML

諮詢委員會或

決定相當於

器材摘要

Dynamo™ Spinal Cement; Salvo® Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260286. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dynamo™ Spinal Cement; Salvo® Spine System?

Dynamo™ Spinal Cement; Salvo® Spine System is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Spine Wave, Inc.. The 510(k) number is K260286.

When did Dynamo™ Spinal Cement; Salvo® Spine System receive FDA 510(k) clearance?

Dynamo™ Spinal Cement; Salvo® Spine System received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260286.

Who is the listed applicant for Dynamo™ Spinal Cement; Salvo® Spine System?

The FDA 510(k) record lists Spine Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamo™ Spinal Cement; Salvo® Spine System?

The FDA product code for Dynamo™ Spinal Cement; Salvo® Spine System is PML.

其他以 Spine Wave, Inc. 為申請人之記錄

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相關器械（代碼：PML）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252885奧林匹克後脊椎固定系統；馬薩達模組化脊椎固定系統Astura Medical K241034Meta+ 骨水泥 & M.U.S.T. 穿孔椎板螺釘系統Medacta International S.A.K231809Momentum® 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥；Momentum® MIS 頸後脊椎固定系統搭配 G21 V-STEADY 骨水泥Ulrich Medical USA K230774PERLA® TL 系統；TEKTONA® HV US 骨水泥Spineart K222789VADER®脊椎系統，G21水泥Icotec AG K221926Invictus®骨水泥，Invictus脊椎固定系統Alphatec Spine, Inc.

官方來源

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