Tenon Medical Passes FDA Level 2 Inspection

Rhea-AI Summary

Tenon Medical, Inc. announced that the US Food and Drug Administration (FDA) has concluded a full Quality System Inspection Technique (QSIT) Level 2 Inspection at Tenon Medical. The inspection found no objectionable conditions or violations of the Food Drug and Cosmetic (FD&C) Act. Tenon Medical received a Pass, indicating their focus on quality and strict operational procedures.

~ 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 angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022 Tenon is focused on three commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) SI Joint fusion adjunct to a spine fusion construct. For more information, please visit https://www.tenonmed.com/.

The Tenon Medical logo, Tenon Medical and Catamaran are registered trademarks of Tenon Medical, Inc.

Safe Harbor

This press release contains "forward-looking statements," which are statements related to events, results, activities or developments that Tenon expects, believes or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," and similar expressions and the negative versions thereof. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 on file with the Securities and Exchange Commission at www.sec.gov, particularly the information contained in the section entitled "Risk Factors". We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.

IR Contact:

Shannon Devine: 203-741-8811
MZ North America
tenon@mzgroup.us

SOURCE: Tenon Medical, Inc.

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FAQ

What did Tenon Medical announce?

Tenon Medical announced that the US Food and Drug Administration (FDA) has concluded a full Quality System Inspection Technique (QSIT) Level 2 Inspection at their company.

What is the purpose of a QSIT inspection?

A QSIT inspection is used to assess a medical device manufacturer's compliance with the Quality System Requirements (QSR) and related regulations.

What is a Form 483?

A Form 483 is issued by the FDA to firm management at the conclusion of an inspection when violations of the Food Drug and Cosmetic (FD&C) Act and related Acts are observed.

Was a Form 483 issued to Tenon Medical?

No, the FDA determined there was no need to issue Form 483 after the inspection at Tenon Medical.

What did the FDA conclude after the inspection?

The FDA concluded that there were no observations or objectionable conditions identified during the inspection at Tenon Medical.

What did Tenon Medical's CEO comment on the inspection?

Tenon Medical's CEO, Steve Foster, commented that the inspection resulted in a Pass for the company, highlighting their focus on quality and strict operational procedures.