← Back to catalogue

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K180818

by Tenon Medical, Inc.

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
10X40mm SIJ Implant FDA UDI
Model / Reference
40295-04 FDA UDI
Description
10X40mm SIJ Implant FDA UDI

Identifiers

Catalog Number
40295-04 FDA UDI
Primary DI / UDI-DI
B74240295040 FDA UDI
510(k) Number
K180818 FDA 510(k)FDA UDI
FDA Product Code
OUR FDA 510(k)FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 10 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) by Tenon Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tenon Medical, Inc.

Sources (2)

  • FDA 510(k) K180818 24 fields · synced Jun 18, 2026
  • FDA UDI 190fa033-b1d7-4574-9edf-d96e7379e46b 37 fields · synced May 27, 2026