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FDA 510(k)

CLASSIC GREAT TOE IMPLANT

K-Number: K023086 · 2002-10-04

ApplicantNexa Orthopedics, Inc.
Decision Date2002-10-04
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLASSIC GREAT TOE 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 2002-10-04 under 510(k) number K023086. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLASSIC GREAT TOE IMPLANT?

CLASSIC GREAT TOE IMPLANT is a medical device that received FDA 510(k) clearance on 2002-10-04. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K023086.

When did CLASSIC GREAT TOE IMPLANT receive FDA 510(k) clearance?

CLASSIC GREAT TOE IMPLANT received FDA 510(k) clearance on 2002-10-04, under 510(k) number K023086.

Who is the listed applicant for CLASSIC GREAT TOE 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 CLASSIC GREAT TOE IMPLANT?

The FDA product code for CLASSIC GREAT TOE IMPLANT is KWH.

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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: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, 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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