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FDA 510(k)

NEXA CARPO METACARPAL IMPLANT

K-Number: K060386 · 2006-05-10

ApplicantNexa Orthopedics, Inc.
Decision Date2006-05-10
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXA CARPO METACARPAL 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 2006-05-10 under 510(k) number K060386. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXA CARPO METACARPAL IMPLANT?

NEXA CARPO METACARPAL IMPLANT is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K060386.

When did NEXA CARPO METACARPAL IMPLANT receive FDA 510(k) clearance?

NEXA CARPO METACARPAL IMPLANT received FDA 510(k) clearance on 2006-05-10, under 510(k) number K060386.

Who is the listed applicant for NEXA CARPO METACARPAL 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 NEXA CARPO METACARPAL IMPLANT?

The FDA product code for NEXA CARPO METACARPAL IMPLANT is KYI.

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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 STAPLEK060071NEXA COMPRESSION SCREWK053408NEXA BONE PLATE AND SCREW SYSTEMK053394NEXA BONE SCREW SYSTEM

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Related Devices (Code: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant AB

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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