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RIVA Posterior Fixation System

FDA UDI

Class II (US FDA UDI)

by Xenix Medical

Identity

Trade Name
RIVA Posterior Fixation System FDA UDI
Generic Name
Spinal bone screw head/rod adaptor FDA UDI
Device Name
Double Head, Polyaxial – Right FDA UDI
Model / Reference
FG1-20-000060 FDA UDI
Description
Double Head, Polyaxial – Right FDA UDI

Identifiers

Catalog Number
FG1-20-000060 FDA UDI
Primary DI / UDI-DI
00840493415444 FDA UDI
510(k) Number
K251154 FDA UDI
FDA Product Code
NKB FDA UDI
KWQ FDA UDI
GMDN Term
Spinal bone screw head/rod adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
Commercial Distribution
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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw head/rod adaptor

RIVA Posterior Fixation System by Xenix Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw head/rod adaptor.

Cleared under the same submission

K251154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xenix Medical

Sources (1)

  • FDA UDI c0a61902-b1a2-43fb-bf02-0e2382d6af4b 35 fields · synced Jun 8, 2026