Home › Device types › MNH
Orthosis, Spondylolisthesis Spinal Fixation
FDA product code MNH · Class 2 · Orthopedic
177,980
Registered devices
4,392
Adverse events
15
Recalls
309
510(k) clearances
Devices with this code
Zodiac — ALPHATEC SPINE, INC.Zodiac — ALPHATEC SPINE, INC.Orthros — CAMBER SPINE TECHNOLOGIES, LLCCanaveral® — FLOSPINE LLCPOLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCPolaris™ 4.75 Spinal System — BIOMET SPINE LLCPolaris™ 6.35 Spinal System — BIOMET SPINE LLCPolaris™ 6.35 Spinal System — BIOMET SPINE LLCCYPHER™ MIS SYSTEM — BIOMET SPINE LLCPOLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCPOLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLCCD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Vitality® — BIOMET SPINE LLCVitality® — BIOMET SPINE LLCSTARFIRE™ Pedicle Screw System — Choice Spine, LPTHUNDERBOLT™ Minimally Invasive Pedicle Screw Systems — Choice Spine, LPBacFix® — ZIMMER SPINE, INC.THUNDERBOLT™ Minimally Invasive Pedicle Screw Systems — Choice Spine, LPSCS Spinal System — Choice Spine, LPSpineTune TL — LDR Spine Usa, Inc.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.DIPLOMAT FT — SIGNUS Medizintechnik GmbHArsenal — ALPHATEC SPINE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-12 | XTANT MEDICAL INC | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. |
| 2016-11-22 | Amendia, Inc | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. |
| 2015-04-07 | X Spine Systems Inc | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. |
| 2015-03-11 | X Spine Systems Inc | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. |
| 2013-01-11 | Synthes USA HQ, Inc. | Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although t |
| 2012-09-25 | Alphatec Spine, Inc. | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Il |
| 2009-07-01 | Stryker Spine | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being a |
| 2009-04-30 | Stryker Spine | The Mantis Rod Inserter Shaft was found to have deformation of the stainless stell split sphere when subjected to high forces, prohibiting the user from being a |
| 2009-04-02 | EBI, L.P. | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
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