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Medtronic Sofamor Danek ANATOMIC PTC. Interbody Fusion Device. Cervical. Non-Bone. Catalog #5030642

  • Writer: CataBlog
    CataBlog
  • Dec 31, 2020
  • 1 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ANATOMIC PEEK PTC Interbody Fusion Device

Vendor/Manufacturer Catalog #: 5030642

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: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code: MAX

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Lumbar


Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Cervical

Category 4: Non-Bone


FDA Premarket Submissions: K192502


SUBSTANTIALLY EQUIVALENT to the following products:


 
 
 

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