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Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA UDI

Class II (US FDA UDI)

by Tenon Medical

Identity

Trade Name
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
Device Name
Access Sterilizing Tray (Trimmed) FDA UDI
Model / Reference
40324 FDA UDI
Description
Access Sterilizing Tray (Trimmed) FDA UDI

Identifiers

Primary DI / UDI-DI
B742403240 FDA UDI
510(k) Number
K180818 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) by Tenon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K180818 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenon Medical

Sources (1)

  • FDA UDI c6c8d5d7-c661-408c-bb46-a9f97c74f852 35 fields · synced May 30, 2026