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510(k) K242302

Device
RejuvaKnee? Collagen Meniscus Implant
Applicant
Collagen Matrix, Inc.
510(k) number
K242302
Product code
OLC
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-02
Date received
2024-08-05
Regulation
878.3300
Classification name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Devin Dragon
Address
15 Thornton Rd. Oakland NJ US 07436 07436

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC2017-05-02
K082079REGEN COLLAGEN SCAFFOLD (CS)Regen Biologics, Inc.2008-12-18