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FDA 510(k)

NEXA BONE SCREW SYSTEM

K-Number: K053394 · 2005-12-14

ApplicantNexa Orthopedics, Inc.
Decision Date2005-12-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXA BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Orthopedics, Inc.. It received FDA 510(k) clearance on 2005-12-14 under 510(k) number K053394. 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 NEXA BONE SCREW SYSTEM?

NEXA BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-14. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K053394.

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

NEXA BONE SCREW SYSTEM received FDA 510(k) clearance on 2005-12-14, under 510(k) number K053394.

Who is the listed applicant for NEXA BONE SCREW SYSTEM?

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

What is the FDA product code for NEXA BONE SCREW SYSTEM?

The FDA product code for NEXA BONE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Nexa Orthopedics, 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.

K072710NEXFIX COMPRESSION PINK071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMK070688NEXFIX COMPRESSION STAPLEK060386NEXA CARPO METACARPAL IMPLANTK060071NEXA COMPRESSION SCREWK053408NEXA BONE PLATE AND SCREW 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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