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510(k) K161404

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System by Genesys Spine — Product Code MAX

K161404 is an FDA 510(k) premarket notification submitted by Genesys Spine for the device "Genesys Spine Apache® Lateral Lumbar Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on July 21, 2016. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Genesys Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2016
Date Received
May 20, 2016
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 Genesys Spine

  • K252322 — SIros-X System (October 22, 2025)
  • K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)
  • K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation (March 29, 2024)
  • K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System (December 13, 2023)
  • K220096 — Genesys Spine 3DP Lumbar Interbody System (March 9, 2022)
  • K191489 — Genesys Spine 3DP Cervical Interbody System (January 8, 2020)
  • K182987 — Genesys Spine 3DP Lumbar Interbody System (December 12, 2019)
  • K192678 — Genesys Spine Binary® Lumbar Plate System (October 24, 2019)
  • K191748 — Genesys Spine Sacroiliac Joint Fusion System (September 26, 2019)
  • K192076 — Binary® Anterior Cervical Plate System (August 29, 2019)

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