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510(k) K082079

Device
REGEN COLLAGEN SCAFFOLD (CS)
Applicant
REGEN BIOLOGICS, INC.
510(k) number
K082079
Product code
OLC  
Decision
Substantially Equivalent (SESE)
Decision date
2008-12-18
Date received
2008-07-23
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
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN DICHIARA
Address
411 Hackensack Ave. Hackensack NJ US 07601 07601

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
K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.2024-10-02
K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC2017-05-02

Legacy Summary#

summary

FDA Review#

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