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510(k) K100805

GALLERY LAMINOPLASTY FIXATION SYSTEM by Biomet Spine (Aka Ebi, LLC) — Product Code NQW

K100805 is an FDA 510(k) premarket notification submitted by Biomet Spine (Aka Ebi, LLC) for the device "GALLERY LAMINOPLASTY FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 2010. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Biomet Spine (Aka Ebi, LLC) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2010
Date Received
March 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

Other clearances by Biomet Spine (Aka Ebi, LLC)

  • K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEM (November 5, 2014)
  • K140710 — BIOMET GRAFT DELIVERY SYRINGES (September 4, 2014)
  • K132373 — BIOMET ACCESS SYSTEM (March 27, 2014)
  • K133746 — POLARIS SPINAL SYSTEM (March 12, 2014)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (February 25, 2013)
  • K123451 — POLARIS SPINAL SYSTEM - BALLISTA II RODS (December 3, 2012)
  • K122989 — BIOMET LATERAL SPACER SYSTEM (October 24, 2012)
  • K122378 — NEXTGEN ALTIUS OCT SYSTEM (September 20, 2012)
  • K113593 — NEXTGEN ALTIUS OCT SYSTEM (April 17, 2012)

Other clearances for product code NQW

  • K252930 — AQUA Laminoplasty Systems (May 27, 2026)
  • K243137 — Curiteva Porous PEEK Laminoplasty System (October 28, 2024)
  • K242784 — Vy Spine™ VyLam™ Laminoplasty System (October 16, 2024)
  • K232471 — Vy Spine™ VyLam™ Laminoplasty System (October 10, 2023)
  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K212428 — Centerpiece Plate Fixation System (December 13, 2021)
  • K191927 — Hinged Laminoplasty System (September 20, 2019)
  • K191169 — NuVasive® Camber Laminoplasty System (July 3, 2019)
  • K181717 — Life Spine Laminoplasty System (October 12, 2018)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)

FDA data resources