← Back to catalogue

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 CUP FOR FX V135 BROACH Ø36+18 FDA UDI
Model / Reference
950-2818 FDA UDI
Description
STANDARD TRIAL FIXED CUP FOR FX V135 BROACH Ø36+18 FDA UDI

Identifiers

Primary DI / UDI-DI
00840452402515 FDA UDI
510(k) Number
K223801 FDA UDI
FDA Product Code
PHX FDA UDI
KWT FDA UDI
HSD 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
888.3650 FDA UDI
888.3690 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

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

Manufacturer

Manufacturer
FX Shoulder Solutions, Inc.

Sources (1)

  • FDA UDI 934e60f5-88fe-4ba3-a621-1d75ce8a3267 34 fields · synced May 30, 2026