SOLANAS Posterior Cervico-Thoracic Fixation System is designed to improve the Spinal Fixation System offered by Alphatec Spine using the axial rod. The Avalon™ Occiptal Fixation System must be used in conjunction with. Alphatec Spine’s SOLANAS Posterior Cervico-Thoracic Fixation System. Alphatec Spine announced the introduction of three new products for with the Solanas posterior cervico-thoracic fixation system, provides the.
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Email to friends Share on Facebook – opens in a new window or tab Share on Twitter – opens in a new window or tab Share on Pinterest – opens in a new window or tab. Dec 26, Failure to promptly correct these violations solaanas result in regulatory action being initiated by the Food and Drug Administration without further notice. Include documentation of the corrective action you have taken.
FDA Warning Letters: Alphatec Spine, Inc. 6/21/10
Carlsbad, CA Why is this contact information displayed? The Company’s Zodiac Degenerative Spinal Fixation System is a spinal system that offers polyaxial pedicle screws, accompanying implants and instruments for the stabilization of the thoracolumbar spine. Also get an email with jobs recommended just for me. Top Global Specialist – Credibility and Experience! Alphatec Solus features a one-step insertion and deployment feature and is used in anterior lumbar interbody fusion ALIF procedures.
We address this response below, in relation to each of the noted violations. However, the event was not reported to the FDA until July 20, These violations include, but are not limited to, the following: Search Now you can search stock related news and private companies such as Airbnb.
The Parties hereto agree that the agreements and covenants herein shall be binding upon the Parties to this Agreement, their heirs, assignees, administrators, executors, successors and legal representatives. Dauchot admitted pro hac vice.
In addition, your procedure lacks key definitions, such as “caused or contributed”, “manufacturer report number” and “permanent”, and full definitions such as “MDR reportable events” and “serious injury”. The Parties hereto agree that this Agreement and the License Agreement contain the entire understanding and agreement reached by the parties and this Agreement and the License Agreement supersede all other written or oral agreements, exchanges, arrangements or negotiations between them or their legal representatives and may not be altered, amended or modified, except by writing properly executed by all Parties hereto.
SET contains weekly cleaning and documentation requirements for the firm’s washers.
Electronics Technician Alphatec SpineInc. The Carlsbad, California-based company said it had a loss of 22 cents per share. Requests for Certificates to Solanxs Governments will not be granted until the violations related to the subject devices have been corrected. Delivery times may vary, especially during peak periods. Try a valid symbol or a specific company name for relevant results. Significant deviations include, but are not limited to, the following: This listing has ended.
Job title, keywords, or company. Distribution Manager Alphatec SpineInc. Class – Surgical, medical, dental, and veterinary apparatus and instruments, artificial limbs, eyes, and teeth; orthopedic articles; suture materials.
Global Orthopaedic Technology
The Parties will thereafter exchange formal signed originals of this Agreement for their permanent records. Add to watch list. Start of add to list layer. Trademark Filing from to now. Material Handler Alphatec SpineInc. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. Its OsseoScrew Alphayec Fixation System is a pedicle screw system that is designed to provide a solution for patients who have poor bone density.
The specific violations noted in this letter and in the Inspectional Observations, Form FDA FDAissued at the closeout of the inspection may be symptomatic of serious problems in your film’s manufacturing and quality assurance systems.