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FDA 510(k)

MAXTORQUE SCREW SYSTEM

K-Number: K131324 · 2013-05-31

ApplicantOrthohelix Surgical Designs, Inc.
Decision Date2013-05-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXTORQUE 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 2013-05-31 under 510(k) number K131324. 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 SCREW SYSTEM?

MAXTORQUE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Orthohelix Surgical Designs, Inc.. The 510(k) number is K131324.

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

MAXTORQUE SCREW SYSTEM received FDA 510(k) clearance on 2013-05-31, under 510(k) number K131324.

Who is the listed applicant for MAXTORQUE 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 SCREW SYSTEM?

The FDA product code for MAXTORQUE 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.

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Related Devices (Code: HWC)

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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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