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Intervertebral Fusion Device With Bone Graft, Lumbar

FDA product code MAX · 785 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3080
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-10-11 – 2026-08-20

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

MAX 2020-01-22

Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus

Applicant Medtronic Sofamor Danek USA, Inc.

K number K192502

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