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FDA 510(k)

HANSEN-STREET TYPE INTRAMEDULLARY NAIL

K-Number: K905348 · 1990-12-11

ApplicantO'Tec Corp.
Decision Date1990-12-11
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HANSEN-STREET TYPE INTRAMEDULLARY NAIL is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905348. 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 HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

HANSEN-STREET TYPE INTRAMEDULLARY NAIL is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is O'Tec Corp.. The 510(k) number is K905348.

When did HANSEN-STREET TYPE INTRAMEDULLARY NAIL receive FDA 510(k) clearance?

HANSEN-STREET TYPE INTRAMEDULLARY NAIL received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905348.

Who is the listed applicant for HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANSEN-STREET TYPE INTRAMEDULLARY NAIL?

The FDA product code for HANSEN-STREET TYPE INTRAMEDULLARY NAIL is KTW.

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Other records listing O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905358CANCELLOUS SCREWK905355BROAD SELF-COMPRESSING PLATEK905347HAGIE PINK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

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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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