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FDA 510(k)

SUBTALAR ARTHRORISIS IMPLANT

K-Number: K032902 · 2003-12-15

ApplicantNexa Orthopedics, Inc.
Decision Date2003-12-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUBTALAR ARTHRORISIS IMPLANT 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 2003-12-15 under 510(k) number K032902. 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 SUBTALAR ARTHRORISIS IMPLANT?

SUBTALAR ARTHRORISIS IMPLANT is a medical device that received FDA 510(k) clearance on 2003-12-15. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K032902.

When did SUBTALAR ARTHRORISIS IMPLANT receive FDA 510(k) clearance?

SUBTALAR ARTHRORISIS IMPLANT received FDA 510(k) clearance on 2003-12-15, under 510(k) number K032902.

Who is the listed applicant for SUBTALAR ARTHRORISIS IMPLANT?

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 SUBTALAR ARTHRORISIS IMPLANT?

The FDA product code for SUBTALAR ARTHRORISIS IMPLANT 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.

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Related Devices (Code: HWC)

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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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