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FDA 510(k)

ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT

K-Number: K862017 · 1986-12-15

ApplicantDyonics, Inc.
Decision Date1986-12-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K862017. 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 ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT?

ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Dyonics, Inc.. The 510(k) number is K862017.

When did ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT receive FDA 510(k) clearance?

ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT received FDA 510(k) clearance on 1986-12-15, under 510(k) number K862017.

Who is the listed applicant for ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT?

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

What is the FDA product code for ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT?

The FDA product code for ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT is HRX.

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Other records listing Dyonics, 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.

K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMK896416DYONICS SHOULDER PORTAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM

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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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