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510(k) K111166

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) by Spineworks, LLC — Product Code MAX

K111166 is an FDA 510(k) premarket notification submitted by Spineworks, LLC for the device "A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)". The FDA issued a decision of Substantially Equivalent on September 8, 2011. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Spineworks, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2011
Date Received
April 26, 2011
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 Spineworks, LLC

  • K133340 — SPINEWORKS ANTERIOR LUMBAR DEVICE (April 11, 2014)
  • K081331 — FIXXSURE CROSS LINK (July 23, 2008)
  • K042600 — STANSION MATRIX (February 18, 2005)

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