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FDA 510(k)

NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

K-Number: K082833 · 2009-02-05

ApplicantNutek Orthopaedics, Inc.
Decision Date2009-02-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Nutek Orthopaedics, Inc.. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K082833. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER?

NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Nutek Orthopaedics, Inc.. The 510(k) number is K082833.

When did NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER receive FDA 510(k) clearance?

NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER received FDA 510(k) clearance on 2009-02-05, under 510(k) number K082833.

Who is the listed applicant for NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER?

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

What is the FDA product code for NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER?

The FDA product code for NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER is KTT.

Related Clinical Trials

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Other records listing Nutek Orthopaedics, 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.

K122777NBX - NON BRIDGING EXTERNAL FIXATOR HAND

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker 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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