Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DynaNail TTC Fusion System

K-Number: K250628 · 2025-09-12

ApplicantMedShape, Inc.
Decision Date2025-09-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaNail TTC Fusion System is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2025-09-12 under approval number K250628. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaNail TTC Fusion System?

DynaNail TTC Fusion System is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by MedShape, Inc.. The 510(k) number is K250628.

When was DynaNail TTC Fusion System approved by the FDA?

DynaNail TTC Fusion System received FDA 510(k) clearance on 2025-09-12, under approval number K250628.

What company makes DynaNail TTC Fusion System?

DynaNail TTC Fusion System is manufactured by MedShape, Inc..

What is the FDA product code for DynaNail TTC Fusion System?

The FDA product code for DynaNail TTC Fusion System is HSB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by MedShape, Inc.

K171376DynaNail TTC Fusion System K181781DynaClipTM Bone Staple K182677DynaNail Mini K193305DynaClip Bone Staple K203381Dynanail Mini Hybrid K220812DynaClip® Bone Staple

View all 10 devices →

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑