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FDA 510(k)

3.5 MM LCP DISTAL HUMERUS SYSTEM

K-Number: K033995 · 2004-03-01

ApplicantSynthes (Usa)
Decision Date2004-03-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3.5 MM LCP DISTAL HUMERUS 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 2004-03-01 under 510(k) number K033995. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.5 MM LCP DISTAL HUMERUS SYSTEM?

3.5 MM LCP DISTAL HUMERUS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Synthes (Usa). The 510(k) number is K033995.

When did 3.5 MM LCP DISTAL HUMERUS SYSTEM receive FDA 510(k) clearance?

3.5 MM LCP DISTAL HUMERUS SYSTEM received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033995.

Who is the listed applicant for 3.5 MM LCP DISTAL HUMERUS 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 3.5 MM LCP DISTAL HUMERUS SYSTEM?

The FDA product code for 3.5 MM LCP DISTAL HUMERUS SYSTEM is KTT.

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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: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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