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Diana

FDA UDI

Class II (US FDA UDI)

by SIGNUS Medizintechnik GmbH

Identity

Trade Name
DIANA FDA UDI
Generic Name
Sacroiliac joint intra-articular arthrodesis implant FDA UDI
Device Name
The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). FDA UDI
Model / Reference
IF-Screw FDA UDI
Description
The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). FDA UDI

Identifiers

Catalog Number
SJ1716 FDA UDI
Primary DI / UDI-DI
04047844008416 FDA UDI
510(k) Number
K091122 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Sacroiliac joint intra-articular arthrodesis implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sacroiliac joint intra-articular arthrodesis implant

Diana by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint intra-articular arthrodesis implant.

Cleared under the same submission

K091122 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SIGNUS Medizintechnik GmbH

Sources (1)

  • FDA UDI c89eb643-0d5f-4cf9-965c-edb9079b8641 38 fields · synced May 30, 2026