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Arthrex, Inc. FDA Approvals

0 new drug approvals and 94 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Arthrex Beaming System510(k)Sep 25, 2026Orthopedic
Arthrex Spine Compression FT Screw510(k)Sep 24, 2026
Arthrex DynaNite Staples510(k)Sep 1, 2026Orthopedic
Arthrex Bioabsorbable PushLock Suture Anchors510(k)Aug 7, 2026Orthopedic
Arthrex Radial Head Replacement System510(k)Jul 30, 2026Orthopedic
Arthrex FiberButton510(k)Jun 26, 2026Orthopedic
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System510(k)Jun 25, 2026Orthopedic
Arthrex Bioabsorbable PushLock Suture Anchors510(k)May 28, 2026Orthopedic
Arthrex Beaming System510(k)May 8, 2026Orthopedic
Arthrex Humeral Nails510(k)Mar 20, 2026Orthopedic
Arthrex FiberTak Suture Anchor510(k)Mar 20, 2026Orthopedic
FiberTape Button510(k)Mar 9, 2026Orthopedic
Arthrex FibuLock Nail System510(k)Mar 5, 2026Orthopedic
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button510(k)Mar 3, 2026Orthopedic
Arthrex Nano FiberTak Suture Anchor510(k)Mar 2, 2026Orthopedic
Arthrex Variable Angle (VA) Proximal Tibia Plating System510(k)Jan 21, 2026Orthopedic
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates510(k)Jan 12, 2026Orthopedic
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm510(k)Dec 30, 2025Orthopedic
Syndesmosis TightRope PRO510(k)Dec 22, 2025Orthopedic
Arthrex SutureTak Suture Anchor510(k)Oct 29, 2025Orthopedic
Arthrex Synergy Vision Imaging System510(k)Oct 16, 2025Gastroenterology, Urology
Arthrex SpeedFLEX™ Implant510(k)Sep 30, 2025General, Plastic Surgery
Arthrex FiberTak Suture Anchor510(k)Jul 18, 2025Orthopedic
Arthrex PushLock Suture Anchors510(k)Jul 10, 2025Orthopedic
Arthrex iBalance Partial Knee System510(k)Jul 1, 2025Orthopedic
SuturePatch Tissue Reinforcement510(k)May 29, 2025General, Plastic Surgery
Arthrex Spine Compression FT Screw510(k)May 22, 2025
Arthrex Spine Endoscope510(k)May 16, 2025Orthopedic
Arthrex Synergy Vision Endoscopic Imaging System510(k)May 5, 2025Gastroenterology, Urology
Arthrex FiberTak Suture Anchor510(k)Mar 28, 2025Orthopedic
Arthrex Humeral Plating System and Cerclage Button510(k)Mar 26, 2025Orthopedic
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor510(k)Mar 14, 2025Orthopedic
Arthrex TightRope Soft Button, RT510(k)Mar 11, 2025Orthopedic
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures510(k)Feb 20, 2025Orthopedic
Arthrex DynaNite Nitinol Staples510(k)Jan 31, 2025Orthopedic
Arthrex NanoScope System510(k)Jan 22, 2025Gastroenterology, Urology
Arthrex Intramedullary Nails510(k)Jan 13, 2025Orthopedic
Arthrex SS VAL and VAL KreuLock™ Compression Screw System510(k)Jan 10, 2025Orthopedic
Arthrex Elbow Fracture Plating System510(k)Nov 14, 2024Orthopedic
Arthrex VAL and VAL KreuLock™ Compression Screw System510(k)Oct 21, 2024Orthopedic
Arthrex Virtual Implant Positioning (VIP) System Software510(k)Oct 2, 2024Orthopedic
Arthrex VAL and VAL KreuLock™ Compression Screw System510(k)Aug 31, 2024Orthopedic
Arthrex Synergy Vision Endoscopic Imaging System510(k)Jul 25, 2024Gastroenterology, Urology
Arthrex Cannulated Screw System510(k)Jun 13, 2024Orthopedic
Arthrex AlloSync PushLock Suture Anchor510(k)Jun 4, 2024Orthopedic
Arthrex TightRope II510(k)May 29, 2024Orthopedic
Univers Revers CA Head and Adapter510(k)Feb 12, 2024Orthopedic
Arthrex Synergy Vision Endoscopic Imaging System510(k)Jan 18, 2024Gastroenterology, Urology
Arthrex Knee FiberTak® Button Suture Anchor510(k)Nov 15, 2023Orthopedic
Arthrex FiberTak Suture Anchor510(k)Nov 3, 2023Orthopedic
Arthrex Small External Fixation System510(k)Oct 18, 2023Orthopedic
Arthrex FiberTape and TigerTape Cerclage Sutures510(k)Oct 6, 2023Orthopedic
Arthrex Univers Apex OptiFit Humeral Stem510(k)Sep 26, 2023Orthopedic
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor510(k)Sep 1, 2023Orthopedic
Arthrex Radiopaque FiberTape Cerclage sutures510(k)Aug 24, 2023Orthopedic
Arthrex TightRope II510(k)Aug 8, 2023Orthopedic
Arthrex Intramedullary Nails510(k)Jul 17, 2023Orthopedic
Arthrex Virtual Implant Positioning (VIP) System510(k)Jun 22, 2023Orthopedic
FiberTak® Suture Anchor510(k)Jun 1, 2023Orthopedic
Arthrex FiberTak Suture Anchor510(k)May 18, 2023Orthopedic
Arthrex Univers Revers Monoblock Stem Size 4/33510(k)Apr 10, 2023Orthopedic
FiberTak Suture Anchor510(k)Apr 1, 2023Orthopedic
Arthrex 3.9 mm SwiveLock Anchor510(k)Mar 17, 2023Orthopedic
Arthrex Knotless FiberTak Suture Anchor510(k)Mar 10, 2023Orthopedic
Arthrex Virtual Implant Positioning (VIP) System510(k)Mar 8, 2023Orthopedic
SutureLoc™ Implant510(k)Feb 2, 2023Orthopedic
Arthrex FiberTak Suture Anchor510(k)Dec 22, 2022Orthopedic
Arthrex DualCompression Hindfoot Fusion Nail Implant System510(k)Dec 20, 2022Orthopedic
Arthrex BioSuture510(k)Oct 27, 2022General, Plastic Surgery
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II510(k)Oct 5, 2022Orthopedic
Arthrex 2.4 mm Volar Distal Radius Plate System510(k)Oct 3, 2022Orthopedic
Arthrex 3.5 mm Locking Compression Plates510(k)Sep 30, 2022Orthopedic
Arthrex Compression FT Pins510(k)Sep 19, 2022Orthopedic
Arthrex SoftStitch510(k)Sep 14, 2022General, Plastic Surgery
Arthrex SutureTape510(k)Sep 9, 2022General, Plastic Surgery
Arthrex Self Punching SwiveLock Suture Anchors510(k)Aug 26, 2022Orthopedic
Arthrex FiberTape and TigerTape Cerclage Sutures510(k)Aug 22, 2022Orthopedic
Arthrex Knotless FiberTak Biceps Suture Anchor510(k)Aug 11, 2022Orthopedic
Arthrex Mini Fragment System510(k)Jun 29, 2022Orthopedic
Arthrex Knotless AC Repair Devices510(k)Jun 6, 2022Orthopedic
Univers Revers Humeral Cup Implant510(k)May 19, 2022Orthopedic
Arthrex Self-Punching PushLock Suture Anchor510(k)May 13, 2022Orthopedic
Arthrx Fracture Plates510(k)May 2, 2022Orthopedic
Arthrex Knotless Mini TightRopes510(k)Dec 17, 2021Orthopedic
Arthrex Vortex Threaded Bone Marrow Recovery Needle510(k)Nov 19, 2021Gastroenterology, Urology
Arthrex Modular Glenoid System-Titanium Glenosphere510(k)Nov 17, 2021Orthopedic
Arthrex LoopLoc Knotless Suture510(k)Oct 25, 2021General, Plastic Surgery
Univers Revers Modular Glenoid System, Standard Augment Baseplates510(k)Sep 2, 2021Orthopedic
Arthrex SynergyID Endoscopic Imaging System510(k)Jul 22, 2021Gastroenterology, Urology
Augmented VaultLock Glenoid510(k)Jun 7, 2021Orthopedic
Arthrex Beveled FT Screws510(k)Jun 1, 2021Orthopedic
Arthrex SwiveLock Anchor510(k)Apr 19, 2021Orthopedic
Arthrex Patella SuturePlates510(k)Mar 25, 2021Orthopedic
Arthrex Pilon Fusion System510(k)Feb 3, 2021Orthopedic

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