146 results found.
            
Amedica Rebrands as SINTX Technologies
Amedica is changing its corporate name to SINTX Technologies to better reflect its focus on core competence in the science and production of silicon nitride ceramics, following...
Amedica Closes Sale of Spine Portfolio to CTL Medical
Amedica completed the sale of its spine business to CTL Medical, which is now exclusive owner of the metal and sil...
Spine Company M&A Picks Up in 3Q18
By Rob Meyer and Julie A. Vetalice Eight—yes, eight—spine acquisitions were announced in the four weeks since we published our analysis, “
Amedica to Divest Spine Business to CTL Medical
CTL Medical will acquire the commercial spine business of Amedica for US $10.0MM. The transaction is slated to c...
Spine Merger & Acquisition Activity Going Strong
By Julie A. Vetalice Updated September 2018 to include additional transactions from 3Q18. Throughout 2017 and thus far in 2018, players of all sizes in the spine segment have taken a variety of steps to fill portfolio gaps, bolster growth and remain competitive. ...
Amedica Announces First Valeo C+CSC Procedure
Amedica marked completion of the first spinal fusion using the Valeo® C+CSC with Lumen interbody fusion device.
Amedica Granted Patent for Silicon Nitride and Ceramic Materials
Amedica was issued a U.S. patent addressing Ceramic and/or Glass Materials and Related Methods....
Amedica Receives FDA Clearance of Valeo C+CsC
Amedica announced FDA 510(k) clearance of the Valeo C+CsC with Lumen interbody fusion device.
Amedica Provides a Business Update
Among its business updates, Amedica announced that the Taurus™ Pedicle Screw generated ~US $1.3MM in 2017 revenue and wa...
Amedica Submits FDA 510(k) for Valeo Implant with Lumen
Amedica made a (510)k submission to FDA for its Valeo C+CSC with Lumen cervical spinal implant.
Amedica 1Q/2Q17 Preliminary Revenue & Business Update
Amedica announced preliminary 1Q17 revenue of US $2.6MM, -37.7% vs. 1Q16, and 2Q17 revenue of $3.2MM...
Trauma and Spine Markets Gain New FDA Clearances
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies that are entering the U.S. market. Nine of the 23 510(k)s were for trauma products an...
Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices
Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS...
Amedica: 2016 Preliminary Results and Business Update
Amedica announced preliminary 2016 revenue of US $15.2MM, -22.2% vs. 2015, and 4Q16 revenue of $3.6M...
Amedica Announces Delayed Filing of Form 10-Q, Receipt of Nasdaq Letter
Amedica delayed the filing of its Quarterly Report on Form 10-Q for 1Q17, and received a listing non-com...
Amedica: Regulatory Clearance for Valeo in Australia
Amedica has been granted marketing clearance in Australia for Valeo® interbody fusion devices.
Amedica Announces Delayed Filing of Form 10-K, Receipt of Nasdaq Letter
Amedica delayed the filing of its Annual Report on Form 10-K for 2016, and announced receipt of a noncompliance letter
Amedica Delays 10-K Filing
Amedica has filed a notification for a 15-day delay in the filing of its Form 10-K Annual Report for 2016.
Member Question: Additively-Manufactured Product Launches
Earlier this year, a Member sent us a question: What portion of new products introduced in joint reconstruction and spine are additively manufactured? This question had been on our radar for some time. Additive manufacturing (AM) has generated more interest than any other topic we&rsq...
Study Results: Independent Femoral Head Wear Testing
Independent study results indicate that mean wear associated with Amedica's MC2® silicon nitride femoral heads
Year in Review: First 510(k)s in 2016
Every month, we examine FDA’s 510(k) database to learn about products heading to market and the companies that intend to bring them there. Here, we’ve captured highlights from that work over the last year.  The following 18 companies received their first FDA 510(k) in 2016...
Amedica's First Taurus Pedicle Screw System Surgery
Amedica announced successful completion of the first surgery using the Taurus™ Pedicle Screw
Amedica Re-files FDA Submission for Modified CsC-based Cervical Implant
Amedica re-filed an application with FDA with a modified cancellous-structured ceramic (CsC)-based cerv...
Strategic orthopaedic-related 510(k)s issued in November 2016
Strategic orthopaedic-related 510(k)s issued in November 2016 include: Preference Elite Pedicle Screw System (Amedica); Titanium Porous Fixat...
KYOCERA Medical Receives FDA 510(k) Clearance for Initia Total Hip
Kyocera Medical received FDA 510(k) clearance for the Initia® Total Hip system, designed for ...
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