Ratchet 510k pg1 - Acumed€¦ · 510(k) Information Note: Although the Trade/Device Name is...

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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.

Transcript of Ratchet 510k pg1 - Acumed€¦ · 510(k) Information Note: Although the Trade/Device Name is...

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

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

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

510k Lap Hexablate K073687

510k Lap Hexablate K073687

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

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

Forearm Fracture Solutions - Acumed...Acumed® Forearm Fracture Solutions Acumed Forearm Fracture Solutions includes plating and rodding systems with a range of diaphyseal radius and

Forearm Fracture Solutions - Acumed...Acumed® Forearm Fracture Solutions Acumed Forearm Fracture Solutions includes plating and rodding systems with a range of diaphyseal radius and

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

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

AirFit F20 (Newcaslte) User Guide AMER - 510K

AirFit F20 (Newcaslte) User Guide AMER - 510K

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

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

Single Use Instruments - Acumed

Single Use Instruments - Acumed

When to Submit a 510k

When to Submit a 510k

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

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

Traditional 510k application - Polymeric Surgical Mesh

Traditional 510k application - Polymeric Surgical Mesh

Surgical Technique - Acumed

Surgical Technique - Acumed

510k Submission Overview

510k Submission Overview

Plates and Nails - Acumed

Plates and Nails - Acumed

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

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

Acumed Ratcheting Compression Palting System€¦ · Acumed® Ratcheting Compression Plating System ... Hub Release Tool (80-1673) Cannulated Drill ... Dissection is carried down

Acumed Ratcheting Compression Palting System€¦ · Acumed® Ratcheting Compression Plating System ... Hub Release Tool (80-1673) Cannulated Drill ... Dissection is carried down

510k Guidance 1

510k Guidance 1

The “New” 510k

The “New” 510k

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

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

Medical Device Regulation: A Primer - NAKFI Device Regulation: A Primer Frances Richmond, PhD ... “The drawing board” as premarket notification (510k) 510k (Class I, II) FDA judges

Medical Device Regulation: A Primer - NAKFI Device Regulation: A Primer Frances Richmond, PhD ... “The drawing board” as premarket notification (510k) 510k (Class I, II) FDA judges