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CATAMARAN™ SIJ Fusion System

FDA UDI

Class II (US FDA UDI)

by Tenon Medical

Identity

Trade Name
CATAMARAN™ SIJ Fusion System FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
Device Name
Implant, CAT-04, 10mm x 40mm FDA UDI
Model / Reference
40295-04 FDA UDI
Description
Implant, CAT-04, 10mm x 40mm FDA UDI

Identifiers

Catalog Number
40295-04 FDA UDI
Primary DI / UDI-DI
00850033676013 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

CATAMARAN™ SIJ Fusion System by Tenon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenon Medical

Sources (1)

  • FDA UDI de5547b7-cbfd-4d56-865d-1dc0f8708778 34 fields · synced May 30, 2026