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FDA 510(k)

BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS

K-Number: K875130 · 1989-01-30

ApplicantOrthopedic Systems, Inc.
Decision Date1989-01-30
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K875130. 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 BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS?

BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K875130.

When did BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS receive FDA 510(k) clearance?

BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS received FDA 510(k) clearance on 1989-01-30, under 510(k) number K875130.

Who is the listed applicant for BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS?

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

What is the FDA product code for BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS?

The FDA product code for BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS is HRX.

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Other records listing Orthopedic Systems, Inc. as applicant

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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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