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510(k) K153695

Biomet Spine Fusion System by Biomet Spine, LLC — Product Code MAX

K153695 is an FDA 510(k) premarket notification submitted by Biomet Spine, LLC for the device "Biomet Spine Fusion System". The FDA issued a decision of Substantially Equivalent on January 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. Biomet Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2016
Date Received
December 23, 2015
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 Biomet Spine, LLC

  • K152622 — Alta ACDF System (July 8, 2016)
  • K151974 — Polaris Spinal System (November 13, 2015)
  • K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge (August 12, 2015)
  • K151483 — Biomet Spine Fusion System (July 31, 2015)
  • K151224 — Lineum OCT Spine System (June 30, 2015)
  • K142634 — Biomet Spine Fusion System (March 12, 2015)
  • K141791 — BIOMET FUSION SYSTEM (October 9, 2014)
  • K141804 — POLARIS SPINAL SYSTEM - HA COATED (September 25, 2014)
  • K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (June 15, 2012)
  • K112014 — ZYSTON STRAIGHT SPACER SYSTEM (October 17, 2011)

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