Orthohelix Surgical Designs, Inc.
Orthohelix Surgical Designs, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2014, with 4 FDA device recalls on record.
Top product codes for Orthohelix Surgical Designs, Inc.
FDA recalls by Orthohelix Surgical Designs, Inc.
- Z-0062-2015 — MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
- Z-0975-2013 — Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
- Z-0026-2013 — OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
- Z-0027-2013 — OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
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 Orthohelix Surgical Designs, Inc.
- K141004 — INTRAOSSEOUS FIXATION SYSTEM
- K142148 — ORTHOHELIX STAPLE SYSTEM
- K141301 — MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
- K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
- K132591 — MAXLOCK EXTREME SYSTEM
- K130832 — ORTHOHELIX STAPLE SYSTEM
- K131324 — MAXTORQUE SCREW SYSTEM
- K123203 — MAXLOCK EXTREME SYSTEM MODEL MXL
- K122005 — MAXLOCK EXTREME SYSTEM
- K121437 — MINI MAXLOCK EXTREME PLATING SYSTEM
- K120165 — INTRAOSSEOUS FIXATION SYSTEM
- K120157 — MINI MAXLOCK EXTREME PLATING SYSTEM
- K113048 — MAXLOCK EXTREME SYSTEM
- K111041 — MINI VARIABLE SYSTEM
- K102156 — MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
- K101962 — MINI MAXLOCK EXTREME PLATING SYSTEM
- K100618 — MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
- K093900 — EDGELOCK
- K090289 — CLAVICLE PLATING SYSTEM
- K082574 — MAXTORQUE MINI CANNULATED SCREW SYSTEM
- K073624 — MODULAR FOOT SYSTEM
- K061400 — CALCANEAL TRAUMA SYSTEM
- K060428 — CSS CANNULATED SCREW SYSTEM
- K053182 — DRLOCK DISTAL RADIUS VOLAR SYSTEM
- K050868 — MAXLOCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.