Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) 40308-01

GUDID B74240308010

Access Sleeve

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile
Primary Device IDB74240308010
NIH Device Record Keyf10bb312-0c72-4c33-8dc8-023872af9b13
Commercial Distribution Discontinuation2021-12-03
Commercial Distribution StatusIn Commercial Distribution
Brand NameCatamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Version Model Number40308-01
Catalog Number40308-01
Company DUNS117014636
Company NameTENON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB74240308010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


[B74240308010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-23
Device Publish Date2020-06-12

On-Brand Devices [Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)]

B742403081607.5mm Insertion Handle
B742403081507.5mm Drill Spacer 5mm
B742403081407.5mm Drill Spacer 10mm
B742403081307.5mm Drill Spacer 20mm
B742403081207.5mm Drill Stop
B742403081107.5mm Extraction Screw
B742403081007.5mm Extraction Fork
B742403080907.5mm Bone Tamp Rod
B742403080707.5mm Location Pin
B742403080607.5mm Drill Guide
B742403080507.5mm Center Punch
B74240308040K-Wire
B74240308030Graduated Guide Wire
B74240308020Access Sleeve Handle
B74240308010Access Sleeve
B7424029504010X40mm SIJ Implant
B7424029503010X30mm SIJ Implant
B742402950207.5X40mm SIJ Implant
B742402950107.5X30mm SIJ Implant
B742403250Implant Sterilizing Tray (Trimmed)
B742403240Access Sterilizing Tray (Trimmed)
B742403230Extraction Sterilizing Tray (Trimmed)
B742403220Drill Sterilizing Tray (Trimmed)
B74240308440Drill Probe
B742403084107.5mm Drill
B742403084004mm Hex Key
B7424030839010mm Bone Tamp Head
B742403083807.5mm Bone Tamp Head
B7424030837010mm Funnel Flange
B742403083607.5mm Funnel Flange
B7424030835010mm Funnel
B742403083407.5mm Funnel
B74240308330Handle Flange
B74240308320Slap Hammer Rod
B74240308310Slap Hammer Handle
B7424030830010mm Insertion Screw
B7424030829010mm Insertion Handle
B7424030828010mm Drill Spacer 5mm
B7424030827010mm Drill Spacer 10mm
B7424030826010mm Drill Spacer 20mm
B7424030825010mm Drill Stop
B7424030824010mm Extraction Screw
B7424030823010mm Extraction Fork
B7424030822010mm Bone Tamp Rod
B7424030821010mm Drill
B7424030820010mm Location Pin
B7424030819010mm Drill Guide
B7424030818010mm Center Punch
B742403081707.5mm Insertion Screw

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