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FDA 510(k)

DJ ORTHOPEDICS TIBIAL ANCHOR

K-Number: K003960 · 2001-03-21

ApplicantDj Orthopedics, LLC
Decision Date2001-03-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DJ ORTHOPEDICS TIBIAL ANCHOR 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 2001-03-21 under 510(k) number K003960. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DJ ORTHOPEDICS TIBIAL ANCHOR?

DJ ORTHOPEDICS TIBIAL ANCHOR is a medical device that received FDA 510(k) clearance on 2001-03-21. The listed applicant is Dj Orthopedics, LLC. The 510(k) number is K003960.

When did DJ ORTHOPEDICS TIBIAL ANCHOR receive FDA 510(k) clearance?

DJ ORTHOPEDICS TIBIAL ANCHOR received FDA 510(k) clearance on 2001-03-21, under 510(k) number K003960.

Who is the listed applicant for DJ ORTHOPEDICS TIBIAL ANCHOR?

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 TIBIAL ANCHOR?

The FDA product code for DJ ORTHOPEDICS TIBIAL ANCHOR is MBI.

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 SYSTEMK010594DJ ORTHOPEDICS POST SCREWK010595DJ ORTHOPEDICS INTERFERENCE SCREWK002829DJ ORTHOPEDICS FEMORAL ANCHOR

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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