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FDA 510(k)

SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM

K-Number: K080153 · 2008-05-14

ApplicantSynthes (Usa)
Decision Date2008-05-14
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) CURVILINEAR DISTRACTION 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 2008-05-14 under 510(k) number K080153. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM?

SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Synthes (Usa). The 510(k) number is K080153.

When did SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM receive FDA 510(k) clearance?

SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM received FDA 510(k) clearance on 2008-05-14, under 510(k) number K080153.

Who is the listed applicant for SYNTHES (USA) CURVILINEAR DISTRACTION 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 (USA) CURVILINEAR DISTRACTION SYSTEM?

The FDA product code for SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM is MQN.

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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: MQN)

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.

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, Inc.

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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