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510(k) K102067

ENDOSKELETON TO by Titan Spine, LLC — Product Code MAX

K102067 is an FDA 510(k) premarket notification submitted by Titan Spine, LLC for the device "ENDOSKELETON TO". The FDA issued a decision of Substantially Equivalent on November 5, 2010. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Titan Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2010
Date Received
July 23, 2010
Clearance Type
Traditional
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 Titan Spine, LLC

  • K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody (January 8, 2020)
  • K192054 — Endoskeleton TAS Plate (August 29, 2019)
  • K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic (August 16, 2019)
  • K191565 — Endoskeleton TCS Interbody Fusion Device (August 6, 2019)
  • K183557 — Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Dev (February 11, 2019)
  • K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Inter (February 13, 2018)
  • K170399 — Endoskeleton TO Interbody Fusion Device (IBD) (July 6, 2017)
  • K163269 — Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic (April 13, 2017)
  • K153122 — Endoskeleton(r) TCS System (December 14, 2015)
  • K151596 — Endoskeleton TCS Interbody Fusion Device (October 9, 2015)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • 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)

FDA data resources