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FDA 510(k)

ODI 7.0MM CANNULATED SCREW SYSTEM

K-Number: K030619 · 2003-04-01

ApplicantOrthopedic Designs, Inc.
Decision Date2003-04-01
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODI 7.0MM CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs, Inc.. It received FDA 510(k) clearance on 2003-04-01 under 510(k) number K030619. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODI 7.0MM CANNULATED SCREW SYSTEM?

ODI 7.0MM CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-01. The listed applicant is Orthopedic Designs, Inc.. The 510(k) number is K030619.

When did ODI 7.0MM CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

ODI 7.0MM CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2003-04-01, under 510(k) number K030619.

Who is the listed applicant for ODI 7.0MM CANNULATED SCREW SYSTEM?

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

What is the FDA product code for ODI 7.0MM CANNULATED SCREW SYSTEM?

The FDA product code for ODI 7.0MM CANNULATED SCREW SYSTEM is HTN.

Related Clinical Trials

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.

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Other records listing Orthopedic Designs, 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.

K014189ODI TALON INTRAMEDULLARY HIP NAILK984331ODI ULTIMATE COMPRESSION HIP SCREWK972722ULTIMATE COMPRESSION SCREW SYSTEM

Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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