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FDA 510(k)

The Simple Locking Intramedullary (Slim) System

K-Number: K192710 · 2020-06-24

ApplicantPega Medical, Inc.
Decision Date2020-06-24
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Simple Locking Intramedullary (Slim) System is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2020-06-24 under 510(k) number K192710. 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 The Simple Locking Intramedullary (Slim) System?

The Simple Locking Intramedullary (Slim) System is a medical device that received FDA 510(k) clearance on 2020-06-24. The listed applicant is Pega Medical, Inc.. The 510(k) number is K192710.

When did The Simple Locking Intramedullary (Slim) System receive FDA 510(k) clearance?

The Simple Locking Intramedullary (Slim) System received FDA 510(k) clearance on 2020-06-24, under 510(k) number K192710.

Who is the listed applicant for The Simple Locking Intramedullary (Slim) System?

The FDA 510(k) record lists Pega Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Simple Locking Intramedullary (Slim) System?

The FDA product code for The Simple Locking Intramedullary (Slim) System is HSB.

Other records listing Pega Medical, 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.

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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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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