CFR | 合法醫療器材資訊網

2018年7月12日 — 1. Introduction ... On October 14, 1999, FDA issued an order reclassifying the polymethylmethacrylate (PMMA) bone cement from class III (premarket ... Read More

2002年7月17日 — This document supersedes “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement 510(k)s; Final Guidance for. Read More

2018年3月23日 — ... that are in contact with tissue or bone cement (e.g., porous coatings). ... 1997 implementation of FDA's Good Guidance Practices, GGP's. Read More

Regulation Description, Polymethylmethacrylate (PMMA) bone cement. Regulation Medical Specialty, Orthopedic. Review Panel, Orthopedic. Product Code, MBB. Read More

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, ... Read More

Device Classification Name, bone cement22. 510(k) Number, K023012. Device Name, SMARTSET HV BONE CEMENT. Applicant. DEPUY ORTHOPAEDICS, INC. Read More

Super Search Devices@FDA 6 ... Device Classification Name, bone cement22. 510(k) Number, K053198. Device Name, SIMPLEX P SPEEDSET BONE CEMENT. Applicant ... Read More