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FDA 510(k)

ARTHREX INSTRUMENTS (WRIST)

K-Number: K926303 · 1994-01-26

ApplicantArthrex, Inc.
Decision Date1994-01-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX INSTRUMENTS (WRIST) is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K926303. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX INSTRUMENTS (WRIST)?

ARTHREX INSTRUMENTS (WRIST) is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Arthrex, Inc.. The 510(k) number is K926303.

When did ARTHREX INSTRUMENTS (WRIST) receive FDA 510(k) clearance?

ARTHREX INSTRUMENTS (WRIST) received FDA 510(k) clearance on 1994-01-26, under 510(k) number K926303.

Who is the listed applicant for ARTHREX INSTRUMENTS (WRIST)?

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

What is the FDA product code for ARTHREX INSTRUMENTS (WRIST)?

The FDA product code for ARTHREX INSTRUMENTS (WRIST) is HRX.

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Other records listing Arthrex, Inc. as applicant

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K262975Arthrex Beaming SystemK262618Arthrex Spine Compression FT ScrewK262451Arthrex DynaNite StaplesK262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButton

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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