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FDA 510(k)

ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL

K-Number: K932593 · 1994-03-10

ApplicantSynthes (Usa)
Decision Date1994-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCESS TO SYNTHES TI-6A1-7NB 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 1994-03-10 under 510(k) number K932593. 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 ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL?

ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Synthes (Usa). The 510(k) number is K932593.

When did ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL receive FDA 510(k) clearance?

ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL received FDA 510(k) clearance on 1994-03-10, under 510(k) number K932593.

Who is the listed applicant for ACCESS TO SYNTHES TI-6A1-7NB 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 ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL?

The FDA product code for ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL is HSB.

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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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