Business
Tenon Medical Passes FDA Level 2 Inspection
~ No Observations, No Objectionable Conditions and No Form 483 Issued ~LOS GATOS, CA / ACCESSWIRE / November 3, 2023 / Tenon Medical, Inc. ("Tenon" or the
About this update from Tenon Medical, Inc.
[{"type":"text","content":"~ No Observations, No Objectionable Conditions and No Form 483 Issued ~LOS GATOS, CA / ACCESSWIRE / November 3, 2023 / Tenon Medical, Inc. (\"Tenon\" or the \"Company\") (NASDAQ:TNON), a company transforming care for patients suffering with certain sacroiliac joint disorders, announced today, the US Food and Drug Administration (FDA) concluded a full Quality System Inspection Technique (QSIT) Level 2 Inspection at Tenon Medical. The QSIT inspection, used to assess a medical device manufacturer's compliance with the Quality System Requirements (QSR) and related regulations, guides the FDA investigators in performing an efficient and effective inspection, focusing on all key elements of a firm's Quality Management System.An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the investigator's judgement, conditions or practices observed would indicate that the device has been adulterated or is being prepared, packed, or held under conditions whereby it may be come adulterated or rendered injurious to health.At the conclusion of the inspection on November 1, 2023, the FDA investigator determined there was no need to issue Form 483 and the Closing Meeting was completed with no observations or objectionable conditions identified. A final report will be issued to the Company over the coming weeks.Tenon Medical's CEO, Steve Foster commented, \"This inspection resulted in a Pass for Tenon Medical which is a tribute to the organization's focus on our quality system. We are proud of our entire team, in particular operations, quality and regulatory groups as their diligence and standardized controls are a testament to the strict operational procedures we put in place at the formation of Tenon.\"About Tenon Medical, Inc.Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran® SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran® Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The...