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510(k) K170364

Device
Collagen Meniscus Implant XL
Applicant
Ivy Sports Medicine, LLC
510(k) number
K170364
Product code
OLC  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-02
Date received
2017-02-06
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
545 Penobscot Dr. Redwood City CA US 94063 94063

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
K082079REGEN COLLAGEN SCAFFOLD (CS)Regen Biologics, Inc.2008-12-18

Legacy Summary#

summary

FDA Review#

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