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FDA 510(k)

INTERLOCKING TIBIAL NAILING SYSTEM

K-Number: K915435 · 1992-03-02

ApplicantStryker Corp.
Decision Date1992-03-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERLOCKING TIBIAL NAILING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915435. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERLOCKING TIBIAL NAILING SYSTEM?

INTERLOCKING TIBIAL NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Stryker Corp.. The 510(k) number is K915435.

When did INTERLOCKING TIBIAL NAILING SYSTEM receive FDA 510(k) clearance?

INTERLOCKING TIBIAL NAILING SYSTEM received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915435.

Who is the listed applicant for INTERLOCKING TIBIAL NAILING SYSTEM?

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

What is the FDA product code for INTERLOCKING TIBIAL NAILING SYSTEM?

The FDA product code for INTERLOCKING TIBIAL NAILING SYSTEM is HSB.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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