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FDA 510(k)

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

K-Number: K103002 · 2011-03-02

ApplicantSynthes (Usa)
Decision Date2011-03-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2011-03-02 under 510(k) number K103002. 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 MULTILOC PROXIMAL HUMERAL NAILING SYSTEM?

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-02. The listed applicant is Synthes (Usa). The 510(k) number is K103002.

When did SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM receive FDA 510(k) clearance?

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM received FDA 510(k) clearance on 2011-03-02, under 510(k) number K103002.

Who is the listed applicant for SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM?

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 MULTILOC PROXIMAL HUMERAL NAILING SYSTEM?

The FDA product code for SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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