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10x40mm SIJ Implant

FDA UDI

Class II (US FDA UDI)

by Tenon Medical

Identity

Trade Name
10x40mm SIJ Implant FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
Device Name
Implant FDA UDI
Model / Reference
CAT-04 FDA UDI
Description
Implant FDA UDI

Identifiers

Catalog Number
CAT-04 FDA UDI
Primary DI / UDI-DI
B74240295041 FDA UDI
510(k) Number
K180818 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
Not 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

10x40mm SIJ Implant 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 a58142ca-1d49-40cc-89e4-abaddd5fc91b 36 fields · synced May 31, 2026