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  • Ratchet 510k pg1 - Acumed€¦ · 510(k) Information Note: Although the Trade/Device Name is identified as the Mediscope Compression Staple and Accessories, ownership of the device
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510(k) Information Note: Although the Trade/Device Name is identified as the Mediscope Compression Staple and Accessories, ownership of the device and associated 510(k) has been transferred to Acumed LLC and is currently marketed as the Acumed Ratcheting Compression Plating System.

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Page 1: Ratchet 510k pg1 - Acumed€¦ · 510(k) Information Note: Although the Trade/Device Name is identified as the Mediscope Compression Staple and Accessories, ownership of the device

510(k) Information

Note: Although the Trade/Device Name is identified as the Mediscope Compression Staple and Accessories, ownership of the device and associated 510(k) has been transferred to Acumed LLC and is currently marketed as the Acumed Ratcheting Compression Plating System.

Page 2: Ratchet 510k pg1 - Acumed€¦ · 510(k) Information Note: Although the Trade/Device Name is identified as the Mediscope Compression Staple and Accessories, ownership of the device

Acumed Brochure EN Modular Hand System...Acumed Brochure EN Modular Hand System Created Date: 12/9/2015 11:04:27 AM

Zeus Scientific Inc. 510K Summary: AtheNA Multi-Lyte ... · 7 3. S1O(k)924096 HSV-1 1. Name of Predicate Device: HerpeSelect 1 and 2 Immunoblot lgG 2. Manufacturer of Predicate Device:

Acumed-SurgicalTechnique-Spanish-Acutrak2-ESSPF00-02-Asmallbonesystem.com/acumed/pdfs/Acumed-SurgicalTechnique-Spa… · Title: Acumed-SurgicalTechnique-Spanish-Acutrak2-ESSPF00-02-A.pdf

Congruent Elbow Plating System - Acumed · Acumed® Congruent Elbow Plating System Designed in conjunction with Shawn W. O’Driscoll, MD, PhD, the Acumed Congruent Elbow Plating

Acumed Case Study - Acumed | Innovation With Purpose

Traditional 510k application - Polymeric Surgical Mesh

Plates and Nails - Acumed

With Second Generation Head Design - Acumed

7.5 mm Screw - Acumed

Acumed Surgical Technique Stableloc External Fixation ...intermedic.com.br/files/downloads/Acumed-Surgical-Technique-EN-S… · Acumed® Stableloc External Fixation System Acumed

AirFit F20 (Newcaslte) User Guide AMER - 510K

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Supplemental Use Guide Foot and Ankle - Acumed › wp-content › uploads › 2017 › 12 › Acumed... · 2017-03-17 · Acumed® Acutrak 2® Headless Compression Screw System—

FDA 510K Clearance Documentation K031759 Cups Device Modification Drug Testing Kits

Surgical echnique - Acumed

Medtech: Global Regulatory Strategy in Medical Device ... · Medtech: Global Regulatory Strategy in Medical Device Product Development May Ng Director, ... - Eg 510k vs PMA, Hong

510k Endoblate K072383

( Picture Archiving and Communication System ) FDA 510K #K072637

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510k Guidance 1

When to Submit a 510k

Department of Biomedical Engineering, University of ... · Abbreviated 510k Special 510k ... vs direct patient benefit (less death from heart disease). ... Special 510(k)

Extremity Screw System - Acumed · Acumed Extremity Screw System The Acumed Extremity Screw System is designed for fracture and osteotomy fixation of the upper and lower extremities

Acutrak Headless Compression Screw - Acumed€¦ · Acutrak® Headless Compression Screw Surgical Technique ... Fusion Device (ATF-XXX-S) ensuring that the trailing end is buried

Surgical echnique - Acumed...Acumed® Calcaneal Plating System Surgical Technique 1 EXPOSURE The recommended surgical approach is lateral right-angled extensile approach (meticulous

Surgical Technique - Acumed

Value Analysis Committee Resource Guide - Acumed

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(Picture Archiving and Communication System) FDA 510K #K072637 (Picture Archiving and Communication System) FDA 510K #K072637 Introduction to

205555Orig1s000 - Food and Drug Administration · Harmonization (ICH) Q3D Guidance on Elemental Impurities. The 510k clearance for Novatech’s Talcair device for talc poudrage for

Surgical echnique - Acumed › system › files › Acumed... · Acumed Polarus 3 Solution Surgical echnique System Features [continued] Low-Profile Screw 4.3 mm low-profile hexalobe

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PoLARUS 2 Locking Humeral Rod - Acumed