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Fx V135

FDA UDI

Class II (US FDA UDI)

by FX Shoulder Solutions, Inc.

Identity

Trade Name
FX V135 FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+18 FDA UDI
Model / Reference
950-4818 FDA UDI
Description
STANDARD TRIAL FIXED 135-145° CUP FOR FX V135 BROACH Ø32+18 FDA UDI

Identifiers

Primary DI / UDI-DI
00840452402638 FDA UDI
510(k) Number
K223801 FDA UDI
FDA Product Code
PHX FDA UDI
HSD FDA UDI
KWT FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
888.3650 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Fx V135 by FX Shoulder Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K223801 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FX Shoulder Solutions, Inc.

Sources (1)

  • FDA UDI c6f99403-8252-4db3-a6cc-c6ee4bd5c242 34 fields · synced Jun 8, 2026