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510(k) K110045

INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE by Vertebral Technologies, Inc. — Product Code MAX

K110045 is an FDA 510(k) premarket notification submitted by Vertebral Technologies, Inc. for the device "INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE". The FDA issued a decision of Substantially Equivalent on February 3, 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. Vertebral Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2011
Date Received
January 6, 2011
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 Vertebral Technologies, Inc.

  • K131540 — INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE (September 3, 2013)
  • K110226 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (May 27, 2011)
  • K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE (October 6, 2010)
  • K093675 — INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 (December 23, 2009)
  • K091988 — MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 (July 30, 2009)
  • K080673 — INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE (June 10, 2008)

Other clearances for product code MAX

  • 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)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)

FDA data resources