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FDA 510(k)

HAGIE PIN

K-Number: K905347 · 1991-01-04

ApplicantO'Tec Corp.
Decision Date1991-01-04
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HAGIE PIN 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 1991-01-04 under 510(k) number K905347. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HAGIE PIN?

HAGIE PIN is a medical device that received FDA 510(k) clearance on 1991-01-04. The listed applicant is O'Tec Corp.. The 510(k) number is K905347.

When did HAGIE PIN receive FDA 510(k) clearance?

HAGIE PIN received FDA 510(k) clearance on 1991-01-04, under 510(k) number K905347.

Who is the listed applicant for HAGIE PIN?

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 HAGIE PIN?

The FDA product code for HAGIE PIN is JDW.

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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 STEMK905333U.S. TYPE CRUCIATE SLOT BONE SCREWK905355BROAD SELF-COMPRESSING PLATEK905358CANCELLOUS SCREWK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

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Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker 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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