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FDA 510(k)

NORMED MINI EXTERNAL FIXATOR SYSTEM

K-Number: K022230 · 2002-09-10

ApplicantOsteomedics, Inc.
Decision Date2002-09-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NORMED MINI EXTERNAL FIXATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomedics, Inc.. It received FDA 510(k) clearance on 2002-09-10 under 510(k) number K022230. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMED MINI EXTERNAL FIXATOR SYSTEM?

NORMED MINI EXTERNAL FIXATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-09-10. The listed applicant is Osteomedics, Inc.. The 510(k) number is K022230.

When did NORMED MINI EXTERNAL FIXATOR SYSTEM receive FDA 510(k) clearance?

NORMED MINI EXTERNAL FIXATOR SYSTEM received FDA 510(k) clearance on 2002-09-10, under 510(k) number K022230.

Who is the listed applicant for NORMED MINI EXTERNAL FIXATOR SYSTEM?

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

What is the FDA product code for NORMED MINI EXTERNAL FIXATOR SYSTEM?

The FDA product code for NORMED MINI EXTERNAL FIXATOR SYSTEM is HRS.

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Other records listing Osteomedics, Inc. 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.

K022035OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORBK022324NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEMK022231NORMED DISTAL RADIUS RECONSTRUCTION SYSTEMK022323NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEMK022325NORMED TITANIUM OSTEOTOMY PLATING SYSTEMK021342NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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