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FDA 510(k)

STERNAL BAND

K-Number: K930015 · 1993-05-19

ApplicantStony Brook Surgical Innovations, Inc.
Decision Date1993-05-19
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERNAL BAND is the device name listed in this FDA 510(k) record. The listed applicant is Stony Brook Surgical Innovations, Inc.. It received FDA 510(k) clearance on 1993-05-19 under 510(k) number K930015. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNAL BAND?

STERNAL BAND is a medical device that received FDA 510(k) clearance on 1993-05-19. The listed applicant is Stony Brook Surgical Innovations, Inc.. The 510(k) number is K930015.

When did STERNAL BAND receive FDA 510(k) clearance?

STERNAL BAND received FDA 510(k) clearance on 1993-05-19, under 510(k) number K930015.

Who is the listed applicant for STERNAL BAND?

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

What is the FDA product code for STERNAL BAND?

The FDA product code for STERNAL BAND is JDQ.

Related Clinical Trials

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.

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Other records listing Stony Brook Surgical Innovations, 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.

K013059STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

Related Devices (Code: JDQ)

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.

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, 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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