Extremity Medical, LLC
Extremity Medical, LLC holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2025, with 4 FDA device recalls on record.
Top product codes for Extremity Medical, LLC
FDA recalls by Extremity Medical, LLC
- Z-0952-2013 — Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
- Z-0752-2013 — Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
- Z-0438-2013 — IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
- Z-0344-2013 — IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Extremity Medical, LLC
- K250536 — MetaFore Small Screw System
- K251128 — Extremity Medical External Fixation System
- K241563 — Extremity Medical External Fixation System
- K212297 — Omni Foot and Ankle Plating System
- K211261 — Axis Charcot Fixation System
- K201556 — Intraosseous Fixation System
- K191525 — KinematX Total Wrist Arthroplasty System
- K192592 — Axis Plating System
- K181067 — AlignX Ankle Fusion System
- K180808 — Omni Foot Plating System
- K172260 — Omni Foot Plating System
- K171018 — Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
- K160191 — Align Anterior Ankle Fusion Plate
- K152710 — HammerFiX Device
- K150309 — Extremity Medical Calcaneal Osteotomy Device
- K150166 — Extremity Medical Suture Anchor
- K143402 — Extremity Medical Calcaneal Osteotomy Device
- K133636 — EXTREMITY MEDICAL HAMMERTOE DEVICE
- K130120 — EXTREMITY MEDICAL IP FUSION SYSTEM
- K121349 — IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
- K121417 — XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
- K101700 — IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
- K093770 — EXTREMITY MEDICAL SCREW SYSTEM
- K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
- K091577 — EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
- K082934 — EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
- K083151 — EXTREMITY MEDICAL SUTURE ANCHOR
- K081934 — EXTREMITY MEDICAL COMPRESSION SCREW
Data sourced from openFDA. This site is unofficial and independent of the FDA.