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8/24/15: September issues of BARE BONES® and ORTHOKNOW® are available!
FDA Calls Out Common Mistakes in Orthopaedic 510(k) Submissions
A new Refuse to Accept policy for 510(k) applications goes into effect October 1. FDA spoke at OMTEC® 2015 on the sticking points of the new guidance and top reasons for deficiencies in orthopaedic device companies’ submissions.
FDA Announces FY16 User Fee Rates
Application fee rates will see a slight rise starting October 1.
Final Look at 2Q15 Revenue
Nearly two dozen companies reported their 1H15 standing in the last month. Notable mentions include inaugural reporting for ConforMIS and SeaSpine and the first call for Zimmer Biomet.
In Memoriam: Jesse Jackson
The Godfather of Orthopaedics in the West is remembered for introducing many to the industry.
7/2/15: Complimentary download! The Japanese Orthopaedic Market.
6/22/15: Speaker Presentations from OMTEC 2015, The 11th Annual Orthopaedic Manufacturing & Technology Exposition and Conference are available for download, here.
6/22/15: We made a small number of updates to the ANNUAL REPORT. Based on new information, we have updated the exhibits on pages 4, 13, 15 and 21. Please download your updated copy here.
New content in Articles of Interest: