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510(k) K101923

CONCORDE CURVE SYSTEM by Depuy Spine — Product Code MAX

K101923 is an FDA 510(k) premarket notification submitted by Depuy Spine for the device "CONCORDE CURVE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 1, 2010. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Depuy Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2010
Date Received
July 9, 2010
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 Depuy Spine

  • K222276 — CONDUIT Cages; FIBERGRAFT BG Putty (October 15, 2022)
  • K201831 — CONFIDENCE Spinal Cement System (August 31, 2020)
  • K142185 — EXPEDIUM VERSE SPINE SYSTEM (November 19, 2014)
  • K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (June 14, 2012)
  • K121020 — VIPER SYSTEM (May 3, 2012)
  • K110353 — MOUNTAINEER OCT SPINAL SYSTEM (April 7, 2011)
  • K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM (April 1, 2011)
  • K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM (January 18, 2011)
  • K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM (December 7, 2010)
  • K103100 — MOUNTAINEER OCT SPINAL SYSTEM (November 17, 2010)

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