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FDA 510(k)

SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM

K-Number: K011458 · 2001-08-02

ApplicantSynthes (Usa)
Decision Date2001-08-02
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2001-08-02 under 510(k) number K011458. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM?

SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM is a medical device that received FDA 510(k) clearance on 2001-08-02. The listed applicant is Synthes (Usa). The 510(k) number is K011458.

When did SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM receive FDA 510(k) clearance?

SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM received FDA 510(k) clearance on 2001-08-02, under 510(k) number K011458.

Who is the listed applicant for SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM?

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 STRAIGHT WRIST FUSION PLATE, 170MM?

The FDA product code for SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM is KTW.

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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: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.K122541ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix SrlK080590AOS PROXIMAL HUMERAL PLATEAdvanced Orthopaedic Solutions, 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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