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FDA 510(k)

FASCILULATED NAIL

K-Number: K854227 · 1986-02-04

ApplicantThe Deca Co.
Decision Date1986-02-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FASCILULATED NAIL is the device name listed in this FDA 510(k) record. The listed applicant is The Deca Co.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854227. 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 FASCILULATED NAIL?

FASCILULATED NAIL is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is The Deca Co.. The 510(k) number is K854227.

When did FASCILULATED NAIL receive FDA 510(k) clearance?

FASCILULATED NAIL received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854227.

Who is the listed applicant for FASCILULATED NAIL?

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

What is the FDA product code for FASCILULATED NAIL?

The FDA product code for FASCILULATED NAIL is HSB.

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Other records listing The Deca Co. 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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