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FDA 510(k)

ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM

K-Number: K964215 · 1996-12-20

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1996-12-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1996-12-20 under 510(k) number K964215. 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 ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM?

ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-20. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K964215.

When did ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM receive FDA 510(k) clearance?

ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM received FDA 510(k) clearance on 1996-12-20, under 510(k) number K964215.

Who is the listed applicant for ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM?

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

What is the FDA product code for ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM?

The FDA product code for ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM is HRX.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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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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