Who is the manufacturer of ULNAR HEAD IMPLANT?

Avanta Orthopaedics, Inc. submitted the Special clearance for ULNAR HEAD IMPLANT (K010786).

What is the FDA product code for ULNAR HEAD IMPLANT?

KXE. It is classified under 21 CFR 888.3810 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ULNAR HEAD IMPLANT?

510(k) clearance (submission type: Special).

ULNAR HEAD IMPLANT

K010786 · Avanta Orthopaedics, Inc. · KXE · Apr 11, 2001 · Orthopedic

Device Facts

Record ID	K010786
Device Name	ULNAR HEAD IMPLANT
Applicant	Avanta Orthopaedics, Inc.
Product Code	KXE · Orthopedic
Decision Date	Apr 11, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3810
Device Class	Class 2

Regulatory Classification

Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.