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Orthohelix Surgical Designs Inc

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sea recall (Z-0062-2015)Orthohelix Surgical Designs Inc2014-10-10
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended recall (Z-0975-2013)Orthohelix Surgical Designs Inc2013-03-22
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The driver recall (Z-0026-2013)Orthohelix Surgical Designs Inc2012-10-09
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The driver recall (Z-0027-2013)Orthohelix Surgical Designs Inc2012-10-09
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Va recall (Z-0421-2012)Orthohelix Surgical Designs Inc2012-01-11
Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: recall (Z-3081-2011)Orthohelix Surgical Designs Inc2011-08-29
CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 recall (Z-0466-2011)Orthohelix Surgical Designs Inc2010-11-26
CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021 recall (Z-0467-2011)Orthohelix Surgical Designs Inc2010-11-26
CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 recall (Z-0468-2011)Orthohelix Surgical Designs Inc2010-11-26
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Des recall (Z-1784-2010)Orthohelix Surgical Designs Inc2010-06-10
Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # recall (Z-1430-2010)Orthohelix Surgical Designs Inc2010-04-22
Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1 recall (Z-1399-2010)Orthohelix Surgical Designs Inc2010-04-15
MaxTorque Cannulated Screw Model # MSD-010-55-060S recall (Z-1250-2010)Orthohelix Surgical Designs Inc2010-04-06
DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four P recall (Z-0136-2008)OrthoHelix Surgical Designs Inc2007-12-19
DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an alum recall (Z-0349-2007)OrthoHelix Surgical Designs Inc2007-01-19
MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with recall (Z-0598-06)Orthohelix Surgical Designs Inc2006-03-09

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Every clearance here is in the API, with alerts when new ones post.