Musculoskeletal Transplant Foundation MTF. Interbody Fusion Device. Lumbar Bone. Catalog #400130

Vendor/Manufacturer: Musculoskeletal Transplant Foundation

Product/Product Line: MTF Interbody Fusion Device

Vendor/Manufacturer Catalog #: 400130

Global Unique Device (GUD) Primary Device Identifier Number:

NA

Global Unique Device (GUD) Device Description:

NA

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

NA

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3045

FDA Regulation Description Classification Name:

Resorbable calcium salt bone void filler device

FDA Classification Product Code: MBP

FDA Classification Product Code Device Name:

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Lumbar

Category 4: Bone

FDA Premarket Submissions: K121313

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. DBX® Deminralized Bone Matrix

2. DBX Strip®

3. The MTF New Bone Void Filler