Product Certifications & Clearance

Spine Solutions

Master CE List – Form-CE-000
ISO Certificate – ISO 13485:2003
CE Certificate – CE 522965

ALEUTIAN and CHESAPEAKE Systems – DOC – 003
CASPIAN Spinal Systems – DOC – 006
CAYMAN Plate Systems – DOC – 005
Cervical Plate Systems – DOC – 002
Interbody Access Systems – DOC – 008
Nile System – DOC – 009
Pedicle Screw Systems – DOC – 001
Corpectomy Cage System – DOC – 010Spine Innovations
Sterile Instrument System – DOC – 004

Our organization demonstrated its ability to provide medical devices that consistently meet customer and regulatory requirements. We accomplished this by recognizing quality as the most important ingredient when manufacturing our product. K2M products have demonstrated their safety and effectiveness both in domestic (pre-market notification, 510(k)) clearance via the FDA (Food and Drug Administration) and overseas (CE Mark).