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FDA 510(k)

ORTHOPEDIC THREADED PIN FIXATION

K-Number: K932349 · 1994-03-01

ApplicantOsteomed Corp.
Decision Date1994-03-01
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC THREADED PIN FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K932349. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC THREADED PIN FIXATION?

ORTHOPEDIC THREADED PIN FIXATION is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Osteomed Corp.. The 510(k) number is K932349.

When did ORTHOPEDIC THREADED PIN FIXATION receive FDA 510(k) clearance?

ORTHOPEDIC THREADED PIN FIXATION received FDA 510(k) clearance on 1994-03-01, under 510(k) number K932349.

Who is the listed applicant for ORTHOPEDIC THREADED PIN FIXATION?

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

What is the FDA product code for ORTHOPEDIC THREADED PIN FIXATION?

The FDA product code for ORTHOPEDIC THREADED PIN FIXATION is JDW.

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Other records listing Osteomed 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.

K022277OSTEOMED CRANIAL FLAP FIXATION SYSTEMK022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEM

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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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