FDA 510(k)

Mg OSTEOREVIVE™, Mg OSTEOCRETE™

K 號：K242372 · 2024-10-18

決定日期2024-10-18

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is the device name listed in this FDA 510(k) record. The listed applicant is Bone Solutions, Inc.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242372. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Bone Solutions, Inc.. The 510(k) number is K242372.

When did Mg OSTEOREVIVE™, Mg OSTEOCRETE™ receive FDA 510(k) clearance?

Mg OSTEOREVIVE™, Mg OSTEOCRETE™ received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242372.

Who is the listed applicant for Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

FDA 510(k) 記錄將 Bone Solutions, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Mg OSTEOREVIVE™, Mg OSTEOCRETE™?

The FDA product code for Mg OSTEOREVIVE™, Mg OSTEOCRETE™ is MQV.

其他以 Bone Solutions, Inc. 為申請人之記錄

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。

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相關器械（代碼：MQV）

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。

K262230Mg 骨回復™；Mg 骨凝合™Bone Solutions, Inc.K260364設備 300419 識別條Geistlich Pharma AG K252797JAZBI™ 可吸收骨空洞填充物Sdip Innovations Pty, Ltd.K261008Vitoss® BiModal 生物活性骨移植代用品泡沫條；Vitoss® BiModal 生物活性骨移植代用品；Vitoss BBTrauma® 生物活性骨移植代用品；Vitoss® BA2X 生物活性骨移植代用品；Vitoss® 生物活性泡沫骨移植代用品包；Vitoss® 生物活性泡沫骨移植代用品；Vitoss® 泡沫骨移植代用品；Vitoss® 骨移植代用品填充罐；Vitoss® 骨移植代用品Stryker Spine K253524Adaptos®Fuse Bone GraftBiomendex OY K253147FIBERGRAFT™ BG 黏土 GPS 骨移植代用品 FIBERGRAFT™ BG 黏土骨移植代用品 FIBERGRAFT™ AERIDYAN™ 維網骨移植代用品 FIBERGRAFT™ BG 維網骨移植代用品Prosidyan, Inc.

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