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Vusion PS

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Vusion PS FDA UDI
Generic Name
Vertebral body prosthesis FDA UDI
Device Name
13 mm 12 Degree Lordotic FDA UDI
Model / Reference
551-5413 FDA UDI
Description
13 mm 12 Degree Lordotic FDA UDI

Identifiers

Catalog Number
551-5413 FDA UDI
Primary DI / UDI-DI
00822409026562 FDA UDI
510(k) Number
K062666 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Vertebral body prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 13 Millimeter FDA UDI
Angle — 12 degree FDA UDI

Vusion PS by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K062666 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI ffa189b5-6379-4c42-a905-bb8f8f8144d6 38 fields · synced Jun 8, 2026