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

Related Records

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