TENON MEDICAL, INC.

FDA Device Registration & Listing · Los Gatos, CA, US · Registration 3015425107

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015425107
FEI Number
3015425107
Entity Name
TENON MEDICAL, INC.
City/State/Country
Los Gatos, CA, US
Establishment Address
104 Cooper Court, Los Gatos, CA 95032, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Tenon Medical, Inc. (Owner Number: 10059873)
Owner / Operator Contact Address
104 Cooper Court, Los Gatos, CA 95032, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250647
PMA Number
N/A

All Registered Proprietary Names

SImmetry SI Joint Fusion System Catamaran Sacroiliac Joint System (CAT SIJ Joint System) SImmetry+ SI Joint Fusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-12-31
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2019-03-03
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tenon Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015425107. Last updated year: 2026. Please use registration number 3015425107 when referencing this establishment in official correspondence.
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