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FDA 510(k)

BIORCI SCREW

K-Number: K992396 · 2000-01-12

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2000-01-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORCI SCREW 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 2000-01-12 under 510(k) number K992396. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIORCI SCREW?

BIORCI SCREW is a medical device that received FDA 510(k) clearance on 2000-01-12. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K992396.

When did BIORCI SCREW receive FDA 510(k) clearance?

BIORCI SCREW received FDA 510(k) clearance on 2000-01-12, under 510(k) number K992396.

Who is the listed applicant for BIORCI SCREW?

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 BIORCI SCREW?

The FDA product code for BIORCI SCREW is HWC. This falls under the Cardiovascular category.

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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: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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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