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FDA 510(k)

NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM

K-Number: K071147 · 2007-07-20

ApplicantNexa Orthopedics, Inc.
Decision Date2007-07-20
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEXA ORTHOPEDICS TOTAL SHOULDER 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 2007-07-20 under 510(k) number K071147. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM?

NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-20. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K071147.

When did NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM receive FDA 510(k) clearance?

NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM received FDA 510(k) clearance on 2007-07-20, under 510(k) number K071147.

Who is the listed applicant for NEXA ORTHOPEDICS TOTAL SHOULDER 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 ORTHOPEDICS TOTAL SHOULDER SYSTEM?

The FDA product code for NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM is KWT.

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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 PINK070688NEXFIX COMPRESSION STAPLEK060386NEXA CARPO METACARPAL IMPLANTK060071NEXA COMPRESSION SCREWK053408NEXA BONE PLATE AND SCREW SYSTEMK053394NEXA BONE SCREW SYSTEM

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Related Devices (Code: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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