Product Classification

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Device starter, bone screw Regulation Description Orthopedic manual surgical instrument. Regulation Medical Specialty Orthopedic Review Panel Orthopedic Product Code HWD Submission Type 510(K) Exempt Regulation Number 888.4540 Device Class 1 GMP Exempt? No     Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. it is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. if a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the u.s. however, these manufacturers are required to register their establishment. please see the registration and listing website for additional information. Recognized Consensus Standards ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure ASTM F1089-02 Standard Test Method for Corrosion of Surgical Instruments ISO 7153-1:1991/Amd. 1:1999 Surgical instruments -- Metallic materials -- Part 1: Stainless steel Third Party Review Not Third Party Eligible