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Katalyst™ Bipolar Radial Head System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Katalyst™ Bipolar Radial Head System FDA UDI
Generic Name
Elbow radius prosthesis FDA UDI
Device Name
Katalyst Radial Head Sizing Wand Instruments FDA UDI
Model / Reference
KATALYSTWANDIMP FDA UDI
Description
Katalyst Radial Head Sizing Wand Instruments FDA UDI

Identifiers

Catalog Number
KATALYSTWANDIMP FDA UDI
Primary DI / UDI-DI
10381780354604 FDA UDI
510(k) Number
K032806 FDA UDI
FDA Product Code
KWI FDA UDI
GMDN Term
Elbow radius prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3170 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Katalyst™ Bipolar Radial Head System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K032806 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 2460095c-214f-40c5-a2cb-c63cd19e5242 37 fields · synced Jun 1, 2026