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K2M Holdings beats on Q3 earnings, misses on sales
K2M (NSDQ:KTWO) yesterday topped the earnings consensus for its third-quarter but missed expectations for sales and lowered its earnings outlook for the rest of the year. The Leesburg, Va.-based orthopedics company posted losses of -$8.5 million, or -20¢ per share, on sales of $62.7 million for the three months ended Sept. 30, widening its losses by 7.0% on sales growth of 5.6% compared with Q3 2016. The results topped Wall Street’s consensus outlook on earnings by a penny but missed The Street’s $66.0 million sales forecast. “Our revenue results for the third quarter of 2017 reflect total reven...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Brad Perriello Tags: MassDevice Earnings Roundup Orthopedics Wall Street Beat K2M Source Type: news

K2M acquires Cardinal Spine ’ s Palo Alto cervical corpectomy cage
K2M (NSDQ:KTWO) said today it acquired Cardinal Spine‘s Palo Alto cervical static corpectomy cage system desigend as a cervical vertebral body replacement device and all associated intellectual property for an undisclosed amount.. Leesburg, Va.-based K2M touted the device as the first and only static corpectomy cage to receive a cervical FDA 510(k) clearance. “We are excited to expand our complex cervical offerings by adding the first and only FDA-cleared static cervical vertebral body replacement device. We look forward to fully integrating this clinically supported technology into our differentiated...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Spinal Cardinal Spine LLC K2M Source Type: news

FDA releases April 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2016 TOTAL 510(k)s THIS PERIOD 239 TOTAL WITH SUMMARIES 224 TOTAL WITH STATEMENTS 15 DEVICE: Applanation Tonometer SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional) ATTN: Weida Zhan PHONE NO : 8621 542 60421 Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16 SHANGHAI CN 200237 510(k) STATEMENT DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Sugentech, Inc. 510(k) NO: K142754(Traditional) ATTN: Mijin Sohn PHONE NO : 82 42 3645001 Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-A...
Source: Mass Device - May 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

NuVasive Receives First Ever FDA 510(k) Clearance Of Cervical Corpectomy Cage
NuVasive, Inc. has received the first ever FDA 510(k) clearance of a cervical corpectomy cage. The X-CoreMini Cervical Corpectomy System is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure. (Source: Medical Design Online News)
Source: Medical Design Online News - October 13, 2015 Category: Medical Equipment Source Type: news

MassDevice.com +3 | The top 3 medtech stories for October 12, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.   3. NuVasive wins FDA nod for X-Core cervical corpectomy cage NuVasive Inc. said that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market. The X-Core device is designed to replace vertebrae in the cervica...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

NuVasive Receives First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage
SAN DIEGO, CA--(Healthcare Sales & Marketing Network) - NuVasive, Inc. (NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the first ever FDA 510(k) cl... Devices, Orthopaedic, Neurosurgery, FDANuVasive, X-Core Mini VBR, corpectomy, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 12, 2015 Category: Pharmaceuticals Source Type: news

NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market. The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with supplemental fixation such as the company’s Archon Reconstruction corpectomy plate. “This assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our cus...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Orthopedics Spinal Nuvasive Source Type: news