FDA inspectors warn NuVasive on marketing for Affix spinal implants

NuVasive logo

Federal regulators warned NuVasive (NSDQ:NUVA) this month about certain promotional claims made in connection with the company’s spinal products.

The FDA in October 2012 inspected NuVasive’s San Diego, Calif., manufacturing facility, finding only the single violation regarding marketing language for the company’s Affix Spinous Process Plate System.

NuVasive had marketed the Affix devices "as an adjunct to interbody fusion (XLIF®, ALIF, PLIF, and TLIF.)," according to the FDA inspection report.

"Although your firm has multiple 510(k)s cleared for this device, none of them include the use of the Affix plate with only an intervertebral body fusion device," the inspectors said. "This constitutes a new intended use and a new 510(k) is required."

NuVasive updated shareholders on the warning letter, noting that the violations relate only to language about the Affix device and that there were no issues with manufacturing at the facility.

"The company takes this matter seriously and has already begun to respond to the FDA’s requests," NuVasive said in a regulatory filing. "The company is giving the matter the highest priority in order to fully address the FDA’s concerns to our mutual satisfaction. As this is an administrative process to address the warning letter, the Company believes the FDA’s concerns can be resolved without an impact on the company’s financial results or operations."

NuVasive doesn’t expect that the issue will affect distribution of devices from the facility, the company added.

RSS From Medical Design & Outsourcing

  • Emuge expands solid carbide thread mill program with new 3XD sizes
    Emuge is now offering an expanded line of Solid Carbide Thread Mills in their popular THREADS-ALL Program, to include new 3XD sizes designed for maximum reach. A total of 17 new sizes have been added, from miniature to standard size tools, providing maximum versatility in a wide range of thread milling applications. The 3XD THREADS-ALL […]
  • Start of helpful humanoid robots? CITEC uses compact LDS component as sensor array
    Editor’s Note: LaserMicronics, a service provider for laser-based manufacturing, has released the whitepaper “Robot hand with a sensitive touch: LDS tactile sensors for sensorimotor skills.” The paper describes a 2014 project from the CITEC department at Bielefeld University in Bielefeld, Germany, where researchers created a tactile sensor resembling a human fingertip. The sensor was then […]
  • Nature meets technology: Festo’s BionicANTs cooperate to solve a common task
    Editor’s Note: Festo, an industrial control and automation company, has released the whitepaper “BionicANTs: Cooperative behavior based on a natural model.” The paper describes the BionicANT, a creation of Festo engineers that duplicates the physical anatomy of its natural counterpart and reproduces the insect’s cooperative behavior. Festo engineers have used the delicate anatomy of an […]
  • Acorn Regulatory streamlines approval process drug-device manufacturers
    Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, is streamlining procedures for U.S. manufacturers of drug-device combinations with customized programs that successfully overcome challenges in meeting European regulatory approvals. Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical […]
  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]

Comments

  1. says

    I simply want to mention I am just newbie to blogs and definitely loved you’re web page. Most likely I’m planning to bookmark your website . You really have amazing stories. Kudos for sharing your blog site.

Trackbacks

  1. Jual Obat Herbal

    Apakah kalian membutuhkan obat herbal de Nature Indonesia silahkan dapat hubungi customer service kita secara langsung lewat SMS ataupun Telepon. Kami selalu online 24 jam utk melayani pembelian obat herbal de Nature.

  2. Nice article

    Apakah kamu membutuhkan obat herbal de Nature Indonesia silahkan dapat hubungi customer service kita secara langsung melalui SMS ataupun Telepon. Kami selalu online 24 jam utk melayani pembelian obat herbal de Nature.

Leave a Reply