10x30mm SIJ Implant CAT-03

GUDID B74240295031

Implant

TENON MEDICAL, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile
Primary Device IDB74240295031
NIH Device Record Key3e7e97c3-2a79-49f7-9390-0d391d987e9f
Commercial Distribution StatusIn Commercial Distribution
Brand Name10x30mm SIJ Implant
Version Model NumberCAT-03
Catalog NumberCAT-03
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB74240295031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


[B74240295031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-31
Device Publish Date2019-05-23

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