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510(k) K131242

ARDIS INTERBODY SYSTEM by Zimmer Spine, Inc. — Product Code MAX

K131242 is an FDA 510(k) premarket notification submitted by Zimmer Spine, Inc. for the device "ARDIS INTERBODY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 3, 2013. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Zimmer Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2013
Date Received
May 1, 2013
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 Zimmer Spine, Inc.

  • K153631 — Zimmer Virage OCT Spinal Fixation System (February 16, 2016)
  • K150896 — Vitality Spinal Fixation System (August 31, 2015)
  • K151031 — Virage OCT Spinal Fixation System (June 24, 2015)
  • K142752 — Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation Syst (June 18, 2015)
  • K143626 — inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plati (March 20, 2015)
  • K143297 — Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Int (February 12, 2015)
  • K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (October 29, 2014)
  • K141500 — OPTIO-C ANTERIOR CERVICAL SYSTEM (September 23, 2014)
  • K133556 — VIRAGE OCT SPINAL FIXATION SYSTEM (June 2, 2014)
  • K140611 — TRINICA ANTERIOR LUMBAR PLATE SYSTEM (May 21, 2014)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • 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)

FDA data resources