Who is the manufacturer of HOWMEDICA BIOABSORBABLE PIN?

Howmedica, Inc. submitted the Traditional clearance for HOWMEDICA BIOABSORBABLE PIN (K955806).

What is the FDA product code for HOWMEDICA BIOABSORBABLE PIN?

HTY. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for HOWMEDICA BIOABSORBABLE PIN?

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

HOWMEDICA BIOABSORBABLE PIN

K955806 · Howmedica, Inc. · HTY · Feb 15, 1996 · Orthopedic

Device Facts

Record ID	K955806
Device Name	HOWMEDICA BIOABSORBABLE PIN
Applicant	Howmedica, Inc.
Product Code	HTY · Orthopedic
Decision Date	Feb 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.