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FDA 510(k)

Collagen Meniscus Implant XL

K-Number: K170364 · 2017-05-02

ApplicantIvy Sports Medicine, LLC
Decision Date2017-05-02
Product CodeOLC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Collagen Meniscus Implant XL is a medical device manufactured by Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2017-05-02 under approval number K170364. The device is classified under product code OLC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagen Meniscus Implant XL?

Collagen Meniscus Implant XL is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Ivy Sports Medicine, LLC. The 510(k) number is K170364.

When was Collagen Meniscus Implant XL approved by the FDA?

Collagen Meniscus Implant XL received FDA 510(k) clearance on 2017-05-02, under approval number K170364.

What company makes Collagen Meniscus Implant XL?

Collagen Meniscus Implant XL is manufactured by Ivy Sports Medicine, LLC.

What is the FDA product code for Collagen Meniscus Implant XL?

The FDA product code for Collagen Meniscus Implant XL is OLC.

Related Clinical Trials

NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING NCT02483988 The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant) COMPLETED NCT05081284 Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix ACTIVE_NOT_RECRUITING NCT05463991 Bioengineered Collagen Implant for Urethral Stricture Repair COMPLETED NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING

Related PubMed Literature

PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025)

Other Devices by Ivy Sports Medicine, LLC

K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

Related Devices (Code: OLC)

K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.

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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