Home GUDID 00810204801408 SIMMETRY+ SI Joint Fusion System
Primary DI 00810204801408
Brand SIMMETRY+ SI Joint Fusion System
Company TENON MEDICAL, INC.
Model 10-P12590-01
Catalog number 10-P12590-01
Device description SImmetry+ Screw 12.5x90 Sharp Tip
Published 2025-12-16
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OUR Sacroiliac Joint Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OUR Sacroiliac Joint Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810204801408 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810204801408 00810204801408 810204801408 0810204801408
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117014636 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810204800005 SImmetry SI Joint Fusion System 10-SL08540-01 10-SL08540-01 2025-12-17 00810204800012 SImmetry SI Joint Fusion System 10-SL08545-00 10-SL08545-00 2025-12-17 00810204800029 SImmetry SI Joint Fusion System 10-SL08550-01 10-SL08550-01 2025-12-17 00810204800036 SImmetry SI Joint Fusion System 10-SL08555-01 10-SL08555-01 2025-12-17 00810204800043 SImmetry SI Joint Fusion System 10-SL08560-01 10-SL08560-01 2025-12-17 00810204800050 SImmetry SI Joint Fusion System 10-SL08565-01 10-SL08565-01 2025-12-17 00810204800067 SImmetry SI Joint Fusion System 10-SL08570-01 10-SL08570-01 2025-12-17 00810204800074 SImmetry SI Joint Fusion System 10-SL08575-01 10-SL08575-01 2025-12-17 00810204800081 SImmetry SI Joint Fusion System 10-SL08580-01 2025-12-17 00810204800098 SImmetry SI Joint Fusion System 10-SL08585-01 10-SL08585-01 2025-12-17 00810204800104 SImmetry SI Joint Fusion System 10-SL08590-01 10-SL08590-01 2025-12-17 00810204800111 SImmetry SI Joint Fusion System 10-SL08595-01 2025-12-17 00810204800128 SImmetry SI Joint Fusion System 10-SL085100-01 10-SL085100-01 2025-12-17 00810204800135 SImmetry SI Joint Fusion System 10-SL085105-01 10-SL085105-01 2025-12-17 00810204800142 SImmetry SI Joint Fusion System 10-SL085110-01 10-SL085110-01 2025-12-17 00810204800159 SImmetry SI Joint Fusion System 10-SL10540-01 2025-12-17 00810204800166 SImmetry SI Joint Fusion System 10-SL10545-01 10-SL10545-01 2025-12-17 00810204800173 SImmetry SI Joint Fusion System 10-SL10550-01 2025-12-17 00810204800180 SImmetry SI Joint Fusion System 10-SL10555-01 10-SL10555-01 2025-12-17 00810204800197 SImmetry SI Joint Fusion System 10-SL10560-01 10-SL10560-01 2025-12-17
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