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Simmetry

FDA UDI

Class II (US FDA UDI)

by Sivantage

Identity

Trade Name
Simmetry FDA UDI
Generic Name
Sacroiliac joint intra-articular arthrodesis implant FDA UDI
Device Name
SImmetry Implant 8.5 mm x 45 mm FDA UDI
Model / Reference
B FDA UDI
Description
SImmetry Implant 8.5 mm x 45 mm FDA UDI

Identifiers

Catalog Number
10-S08545-01 FDA UDI
Primary DI / UDI-DI
00810142530019 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Sacroiliac joint intra-articular arthrodesis implant 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Sacroiliac joint intra-articular arthrodesis implant

Simmetry by Sivantage — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint intra-articular arthrodesis implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sivantage

Sources (1)

  • FDA UDI c85e57b1-18ee-4129-8629-45a7ed749024 36 fields · synced May 31, 2026