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FDA 510(k)

DJ ORTHOPEDICS INTERFERENCE SCREW

K-Number: K010595 · 2001-05-08

ApplicantDj Orthopedics, LLC
Decision Date2001-05-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DJ ORTHOPEDICS INTERFERENCE 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 2001-05-08 under 510(k) number K010595. 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 INTERFERENCE SCREW?

DJ ORTHOPEDICS INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Dj Orthopedics, LLC. The 510(k) number is K010595.

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

DJ ORTHOPEDICS INTERFERENCE SCREW received FDA 510(k) clearance on 2001-05-08, under 510(k) number K010595.

Who is the listed applicant for DJ ORTHOPEDICS INTERFERENCE 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 INTERFERENCE SCREW?

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

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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 SYSTEMK010594DJ ORTHOPEDICS POST 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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