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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K262061
Device Name Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM
Applicant
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact Kristina Daoud
Correspondent
Stryker Spine
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP   OVD   PLR  
Date Received06/18/2026
Decision Date 07/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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