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510(k) K110694

CONCORDE BULLET SPINAL SYSTEM by Johnson & Johnson — Product Code MAX

K110694 is an FDA 510(k) premarket notification submitted by Johnson & Johnson for the device "CONCORDE BULLET SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 11, 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. Johnson & Johnson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2011
Date Received
March 14, 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 Johnson & Johnson

  • K142460 — EXPEDIUM Spine System/Synapse System (October 1, 2014)
  • K113273 — SPOTLIGHT ACCESS SYSTEM (January 27, 2012)
  • K112913 — SPOTLIGHT ACCESS SYSTEM (December 16, 2011)
  • K113348 — COUGAR SYSTEM (December 13, 2011)
  • K110551 — EXPEDIUM SPINE SYSTEM (October 26, 2011)
  • K111571 — VIPER SYSTEMS (July 6, 2011)
  • K110454 — COUGAR LS LATERAL CAGE SYSTEM (May 13, 2011)
  • K103743 — CONCORDE CURVE SYSTEM (March 17, 2011)
  • K103488 — CONCORDE BULLET CAGE SYSTEM (March 2, 2011)
  • K103490 — EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM (February 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