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FDA 510(k)

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW

K-Number: K132893 · 2013-11-20

ApplicantIcon Orthopaedic Concepts Dba Edge Orthopaedics
Decision Date2013-11-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Icon Orthopaedic Concepts Dba Edge Orthopaedics. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K132893. 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 EDGE ORTHOPAEDICS BITE COMPRESSION SCREW?

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Icon Orthopaedic Concepts Dba Edge Orthopaedics. The 510(k) number is K132893.

When did EDGE ORTHOPAEDICS BITE COMPRESSION SCREW receive FDA 510(k) clearance?

EDGE ORTHOPAEDICS BITE COMPRESSION SCREW received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132893.

Who is the listed applicant for EDGE ORTHOPAEDICS BITE COMPRESSION SCREW?

The FDA 510(k) record lists Icon Orthopaedic Concepts Dba Edge Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDGE ORTHOPAEDICS BITE COMPRESSION SCREW?

The FDA product code for EDGE ORTHOPAEDICS BITE COMPRESSION SCREW is HWC. This falls under the Cardiovascular category.

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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.

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Official Source

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

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