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FDA 510(k)

NBX - NON BRIDGING EXTERNAL FIXATOR HAND

K-Number: K122777 · 2013-05-15

ApplicantNutek Orthopaedics, Inc.
Decision Date2013-05-15
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NBX - NON BRIDGING EXTERNAL FIXATOR HAND 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 2013-05-15 under 510(k) number K122777. 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 HAND?

NBX - NON BRIDGING EXTERNAL FIXATOR HAND is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Nutek Orthopaedics, Inc.. The 510(k) number is K122777.

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

NBX - NON BRIDGING EXTERNAL FIXATOR HAND received FDA 510(k) clearance on 2013-05-15, under 510(k) number K122777.

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

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 HAND?

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

Related Clinical Trials

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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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.

K082833NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, 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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