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FDA 510(k)

RejuvaKnee™ Collagen Meniscus Implant

K-Number: K242302 · 2024-10-02

ApplicantCollagen Matrix, Inc.
Decision Date2024-10-02
Product CodeOLC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RejuvaKnee™ Collagen Meniscus Implant is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K242302. 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 RejuvaKnee™ Collagen Meniscus Implant?

RejuvaKnee™ Collagen Meniscus Implant is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K242302.

When did RejuvaKnee™ Collagen Meniscus Implant receive FDA 510(k) clearance?

RejuvaKnee™ Collagen Meniscus Implant received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242302.

Who is the listed applicant for RejuvaKnee™ Collagen Meniscus Implant?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RejuvaKnee™ Collagen Meniscus Implant?

The FDA product code for RejuvaKnee™ Collagen Meniscus Implant is OLC.

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.

NCT05081284Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen MatrixACTIVE_NOT_RECRUITINGNCT07782125Volume-Stable Collagen Matrix vs. Connective Tissue Graft for Peri-Implant Soft Tissue DefectsRECRUITING

Other records listing Collagen Matrix, 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.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra MoldableK221735Mineral Collagen Composite Bioactive Moldable

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Related Devices (Code: OLC)

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.

K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC

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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