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FDA 510(k)

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

K-Number: K923580 · 1993-01-21

ApplicantSynthes (Usa)
Decision Date1993-01-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K923580. 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 SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL?

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Synthes (Usa). The 510(k) number is K923580.

When did SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL receive FDA 510(k) clearance?

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL received FDA 510(k) clearance on 1993-01-21, under 510(k) number K923580.

Who is the listed applicant for SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL?

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

What is the FDA product code for SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL?

The FDA product code for SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL is HSB.

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Other records listing Synthes (Usa) 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.

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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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