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510(k) K200613

Tritanium® X TL Expandable Curved Posterior Lumbar Cage by Stryker Corporation — Product Code MAX

K200613 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Tritanium® X TL Expandable Curved Posterior Lumbar Cage". The FDA issued a decision of Substantially Equivalent on April 15, 2020. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2020
Date Received
March 9, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

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

Other clearances by Stryker Corporation

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  • K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker an (February 16, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)
  • K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ A (October 19, 2022)
  • K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Devic (September 16, 2022)
  • K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele (July 12, 2022)
  • K213824 — Sonopet iQ Ultrasonic Aspirator System (February 3, 2022)
  • K212055 — Connected OR Hub with Device and Voice Control (December 16, 2021)
  • K210377 — Stryker iBur hubs and cutting accessories (June 30, 2021)
  • K202964 — iBed Wireless with iBed Mobile (June 18, 2021)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources