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X-Psi™

FDA UDI

Class II (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name
X-PSI™ FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Model / Reference
20-8017-031-00 FDA UDI

Identifiers

Catalog Number
20-8017-031-00 FDA UDI
Primary DI / UDI-DI
00889024486713 FDA UDI
510(k) Number
K171269 FDA UDI
FDA Product Code
JWH FDA UDI
OOG FDA UDI
MBH FDA UDI
LLZ FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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: Orthopaedic prosthesis implantation positioning instrument, single-use

X-Psi™ by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Cleared under the same submission

K171269 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosoft Inc

Sources (1)

  • FDA UDI c543edfe-85f0-4bb8-92ce-f431d5594ef1 35 fields · synced May 30, 2026