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510(k) K240507

NuVasive AttraX Scaffold by Nuvasive, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2024
Date Received
February 21, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Nuvasive, Inc.

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  • K223731 — NuVasive Modulus-C Interbody System (January 12, 2023)
  • K211757 — Simplify Disc (August 20, 2021)
  • K173117 — NuVasive® VersaTie™ System (December 7, 2017)
  • K141665 — NuVasive CoRoent System (March 13, 2015)
  • K142205 — NuVasive X-CORE(R) Expandable VBR System (February 20, 2015)
  • K141968 — NUVASIVE NVM5 SYSTEM (November 14, 2014)
  • K140319 — COROENT TI-C SYSTEM (October 9, 2014)
  • K140162 — AP EXPANDABLE XLIF SYSTEM (July 2, 2014)
  • K140003 — COROENT SMALL INTERBODY SYSTEM (April 3, 2014)

Other clearances for product code MQV

  • K253524 — Adaptos®Fuse Bone Graft (February 17, 2026)
  • K253147 — FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft S (October 22, 2025)
  • K251522 — Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (October 13, 2025)
  • K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix (September 30, 2025)
  • K251556 — Device 300423 Granules (July 17, 2025)
  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
  • K243474 — MagnetOs MIS (May 23, 2025)
  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)