OLC

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

产品代码

OLC

器械名称

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.3300

FDA 专业组

General, Plastic Surgery

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

该代码近三年的 510(k)

1 件

其中 Summary 已存档

1 份，可直接下载

FDA 历史累计 510(k)

3 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2024-10-02。

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。