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FDA 510(k)

DJ ORTHOPEDICS POST SCREW

K-Number: K010594 · 2001-05-29

ApplicantDj Orthopedics, LLC
Decision Date2001-05-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DJ ORTHOPEDICS POST SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Dj Orthopedics, LLC. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K010594. 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 DJ ORTHOPEDICS POST SCREW?

DJ ORTHOPEDICS POST SCREW is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Dj Orthopedics, LLC. The 510(k) number is K010594.

When did DJ ORTHOPEDICS POST SCREW receive FDA 510(k) clearance?

DJ ORTHOPEDICS POST SCREW received FDA 510(k) clearance on 2001-05-29, under 510(k) number K010594.

Who is the listed applicant for DJ ORTHOPEDICS POST SCREW?

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

What is the FDA product code for DJ ORTHOPEDICS POST SCREW?

The FDA product code for DJ ORTHOPEDICS POST SCREW is HWC. This falls under the Cardiovascular category.

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 Dj Orthopedics, LLC 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.

K021740TOTAL KNEE CEMENTED, SEMI-CONSTRAINEDK011354HIGH TIBIAL OSTEOTOMY PLATING SYSTEMK010595DJ ORTHOPEDICS INTERFERENCE SCREWK002829DJ ORTHOPEDICS FEMORAL ANCHORK003960DJ ORTHOPEDICS TIBIAL ANCHOR

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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