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510(k) K123909

AESCULAP CESPACE XP by Aesculap Implant System, Inc. — Product Code ODP

K123909 is an FDA 510(k) premarket notification submitted by Aesculap Implant System, Inc. for the device "AESCULAP CESPACE XP". The FDA issued a decision of Substantially Equivalent on April 15, 2013. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Aesculap Implant System, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2013
Date Received
December 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Aesculap Implant System, Inc.

  • K142707 — AIS Odontoid Fracture Fixation System (December 19, 2014)
  • K142150 — AIS MODULIFT VBR SYSTEM (October 29, 2014)
  • K133802 — AIS MODULIFT VBR SYSTEM (April 17, 2014)
  • K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (October 30, 2013)
  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)
  • K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (July 23, 2010)

Other clearances for product code ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (August 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)

FDA data resources