FDA 510(k)

DB-骨科設備

K 號：K200752 · 2020-04-22

決定日期2020-04-22

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

DB-Orthopedics is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K200752. 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 DB-Orthopedics?

DB-Orthopedics is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Dimensional Bioceramics, LLC. The 510(k) number is K200752.

When did DB-Orthopedics receive FDA 510(k) clearance?

DB-Orthopedics received FDA 510(k) clearance on 2020-04-22, under 510(k) number K200752.

Who is the listed applicant for DB-Orthopedics?

The FDA 510(k) record lists Dimensional Bioceramics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DB-Orthopedics?

The FDA product code for DB-Orthopedics is MQV.

其他以 Dimensional Bioceramics, LLC 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。

K212353DB-EZ 骨空洞填充物 K210193DB-複合 K182742DB-CMF K171161維度生物陶瓷硫酸鈣設備（DB-CSD）

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.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。