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Orthofix Medical (OFIX) FDA Events

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FDA Events for Orthofix Medical (OFIX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Orthofix Medical (OFIX). Over the past two years, Orthofix Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Orthofix's and TrueLok. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Orthofix Medical's Drugs in FDA Review

Orthofix's proprietary Pulsed Electromagnetic Field - FDA Regulatory Timeline and Events

Orthofix's proprietary Pulsed Electromagnetic Field is a drug developed by Orthofix Medical for the following indication: Patients treated with the SpinalStim™ bone growth therapy device. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TrueLok EVO Ring Fixation System - FDA Regulatory Timeline and Events

TrueLok EVO Ring Fixation System is a drug developed by Orthofix Medical for the following indication: Complex limb reconstruction and deformity correction procedures. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Orthofix Medical FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Orthofix Medical (OFIX) has reported FDA regulatory activity for the following drugs: TrueLok EVO Ring Fixation System and Orthofix's proprietary Pulsed Electromagnetic Field.

The most recent FDA-related event for Orthofix Medical occurred on March 19, 2025, involving TrueLok EVO Ring Fixation System. The update was categorized as "FDA Clearance," with the company reporting: "Orthofix Medical Inc announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System."

Current therapies from Orthofix Medical in review with the FDA target conditions such as:

  • Complex limb reconstruction and deformity correction procedures - TrueLok EVO Ring Fixation System
  • Patients treated with the SpinalStim™ bone growth therapy device - Orthofix's proprietary Pulsed Electromagnetic Field

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:OFIX) was last updated on 7/10/2025 by MarketBeat.com Staff
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