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FDA 510(k)

MAGELLAN TIBIAL INTRAMEDULLARY NAIL

K-Number: K992850 · 2000-03-10

ApplicantOrthomatrix, Inc.
Decision Date2000-03-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGELLAN TIBIAL INTRAMEDULLARY NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Orthomatrix, Inc.. It received FDA 510(k) clearance on 2000-03-10 under 510(k) number K992850. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGELLAN TIBIAL INTRAMEDULLARY NAIL?

MAGELLAN TIBIAL INTRAMEDULLARY NAIL is a medical device that received FDA 510(k) clearance on 2000-03-10. The listed applicant is Orthomatrix, Inc.. The 510(k) number is K992850.

When did MAGELLAN TIBIAL INTRAMEDULLARY NAIL receive FDA 510(k) clearance?

MAGELLAN TIBIAL INTRAMEDULLARY NAIL received FDA 510(k) clearance on 2000-03-10, under 510(k) number K992850.

Who is the listed applicant for MAGELLAN TIBIAL INTRAMEDULLARY NAIL?

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

What is the FDA product code for MAGELLAN TIBIAL INTRAMEDULLARY NAIL?

The FDA product code for MAGELLAN TIBIAL INTRAMEDULLARY NAIL is HSB.

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Other records listing Orthomatrix, 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.

K010738CANNULATED PLUS SCREW SYSTEMK001254ORTHOMATRIX, INC. CERCLAGE SYSTEMK992856MAGELLAN HUMERAL INTRAMEDULLARY NAILK852766HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTIK852765HA-2000 HYDROXYLAPATITEK851367HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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