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FDA 510(k)

MAXTORQUE MINI CANNULATED SCREW SYSTEM

K-Number: K082574 · 2008-12-08

ApplicantOrthohelix Surgical Designs, Inc.
Decision Date2008-12-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXTORQUE MINI CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthohelix Surgical Designs, Inc.. It received FDA 510(k) clearance on 2008-12-08 under 510(k) number K082574. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXTORQUE MINI CANNULATED SCREW SYSTEM?

MAXTORQUE MINI CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-08. The listed applicant is Orthohelix Surgical Designs, Inc.. The 510(k) number is K082574.

When did MAXTORQUE MINI CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

MAXTORQUE MINI CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2008-12-08, under 510(k) number K082574.

Who is the listed applicant for MAXTORQUE MINI CANNULATED SCREW SYSTEM?

The FDA 510(k) record lists Orthohelix Surgical Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXTORQUE MINI CANNULATED SCREW SYSTEM?

The FDA product code for MAXTORQUE MINI CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Orthohelix Surgical Designs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132591MAXLOCK EXTREME SYSTEMK130832ORTHOHELIX STAPLE SYSTEMK131324MAXTORQUE SCREW SYSTEMK123203MAXLOCK EXTREME SYSTEM MODEL MXLK122005MAXLOCK EXTREME SYSTEMK121437MINI MAXLOCK EXTREME PLATING SYSTEM

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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