← Back to catalogue

Virage OCT Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Highridge Medical, LLC

Identity

Trade Name
Virage OCT Spinal Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Channel Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm) FDA UDI
Model / Reference
300P0009 FDA UDI
Description
Channel Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm) FDA UDI

Identifiers

Catalog Number
300P0009 FDA UDI
Primary DI / UDI-DI
03662663080088 FDA UDI
510(k) Number
K250332 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

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
MRI Safety
MR Conditional FDA UDI

Category: Bone-screw internal spinal fixation system connector

Virage OCT Spinal Fixation System by Highridge Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K250332 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Highridge Medical, LLC

Sources (1)

  • FDA UDI 3e967cdd-7e14-4823-b31b-955c94148fe2 36 fields · synced May 29, 2026