Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Brought to you by ORTHOWORLD

Articles Tagged "premarket approval"

DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle

by BONEZONE | Nov 2017

The Hintermann Series H2 is a semi-constrained cemented prosthesis for primary or revision surgery, also indicated to treat failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »

FDA Outlines Stance on ex-U.S. Clinical Data

by Hannah Corcoran | Jun 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes Priorities for 2015

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Player Profiles

Featured Video

Phillips Precision Medicraft Principles
by: Phillips Precision Medicraft 
 

 
Phillips Precision Medicraft, a manufacturer of advanced orthopedic implants, instrumentation, sterilization delivery systems, cases and trays, meets the complex demands of its customers by investing in people, LEAN, 5S and state-of-the-art manufacturing equipment. (Originally a guest spotlight on the Fox Business News Channel.)

All Videos

Featured White Paper

Raise Your Packaging IQ: Characterizing Equipment Input Variation


Device packaging is an integral part of product commercialization that cannot be underestimated, given its impact on your device long after implementation. Millstone Medical’s study of the heat sealing process reveals that variability in peak peel strength of nylon pouches can be reduced by making...


All White Papers

Featured Classified

Hiring Managers - See Your Ad Here!


Leverage BONEZONE to secure your next 
all-star hire! Readers include R&D, 
Engineers, Manufacturing & Operations, 
Purchasing & Procurement and Executive 
Management professionals.
 

ALL CLASSIFIEDS

  • ORTHOWORLD Inc.
  • 8401 Chagrin Road, Suite 18
  • Chagrin Falls, Ohio 44023 USA
  • Phone: 440.543.2101 | Fax: 440.543.2122
  • ©1992-2018 ORTHOWORLD
  • All Rights Reserved.
  • Site Managed By:
  • Open Professional Group
  • ORTHOWORLD®, BONEZONE® and the O® are registered trademarks of ORTHOWORLD Inc.