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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, non-sterile FDA UDI
Device Name
Lid, Sterilization Tray, Catamaran FDA UDI
Model / Reference
40304 FDA UDI
Description
Lid, Sterilization Tray, Catamaran FDA UDI

Identifiers

Catalog Number
40304 FDA UDI
Primary DI / UDI-DI
00850033676266 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
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

Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile

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, non-sterile.

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 61aa1516-cb10-4b6e-9477-8f7e76664224 35 fields · synced Jun 1, 2026