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FDA 510(k)

ODI ULTIMATE COMPRESSION HIP SCREW

K-Number: K984331 · 1999-01-20

ApplicantOrthopedic Designs, Inc.
Decision Date1999-01-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODI ULTIMATE COMPRESSION HIP SCREW 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 1999-01-20 under 510(k) number K984331. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODI ULTIMATE COMPRESSION HIP SCREW?

ODI ULTIMATE COMPRESSION HIP SCREW is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Orthopedic Designs, Inc.. The 510(k) number is K984331.

When did ODI ULTIMATE COMPRESSION HIP SCREW receive FDA 510(k) clearance?

ODI ULTIMATE COMPRESSION HIP SCREW received FDA 510(k) clearance on 1999-01-20, under 510(k) number K984331.

Who is the listed applicant for ODI ULTIMATE COMPRESSION HIP SCREW?

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 ULTIMATE COMPRESSION HIP SCREW?

The FDA product code for ODI ULTIMATE COMPRESSION HIP SCREW is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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.

K030619ODI 7.0MM CANNULATED SCREW SYSTEMK014189ODI TALON INTRAMEDULLARY HIP NAILK972722ULTIMATE COMPRESSION SCREW SYSTEM

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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