Who is the manufacturer of MITEK THREADED ANCHOR (FASTIN)?

Mitek Surgical Products, Inc. submitted the Traditional clearance for MITEK THREADED ANCHOR (FASTIN) (K953560).

What is the FDA product code for MITEK THREADED ANCHOR (FASTIN)?

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

What is the regulatory pathway for MITEK THREADED ANCHOR (FASTIN)?

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

MITEK THREADED ANCHOR (FASTIN)

K953560 · Mitek Surgical Products, Inc. · MBI · Jan 31, 1996 · Orthopedic

Device Facts

Record ID	K953560
Device Name	MITEK THREADED ANCHOR (FASTIN)
Applicant	Mitek Surgical Products, Inc.
Product Code	MBI · Orthopedic
Decision Date	Jan 31, 1996
Decision	SN
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.