with Nanotechnology consists of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected …
Premarket Approval (PMA)
Dec 1, 2025 · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those …
Recognized Consensus Standards: Medical Devices
Jul 28, 2025 · Recognized Consensus Standards: Medical DevicesFDA Home Medical Devices Databases
The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.
aces of the DYNAMISTM TRU-NANO Screws incorporate a micro- and nano-roughened sur s the requirements for nanotechnology. The surface of the screws have been delibe ately …
Recognized Consensus Standards: Medical Devices
FDA Home Medical Devices Databases - 1 result found Recognition Number: 18-24 Results per Page 5 10 25 50 100 500
The nanoLOCK™ surface technology demonstrates the elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. New bone …
Recognized Consensus Standards: Medical Devices
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Device materials are standard medical grade materials - no materials of animal origin or nanotechnology. Device inserted via the nostrils - target location is the nasal cavity in the area …
IV. Manufacturing Summary: Critical Issues and Complexities Does the submission contain any of the following elements? Nanotechnology RTRT Proposal PAT Drug/Device Combo