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OLCClass II

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

21 CFR 878.3300 / General, Plastic Surgery

OLC is the FDA product code for Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OLC
Device name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
FDA definition
Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code OLC

By decision year
3 clearances under product code OLC with a decision year between 2008 and 2024, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OLC by decision year
YearClearances
20081
20171
20241

Applicants with the most clearances

Product code OLC
Applicants holding the most 510(k) clearances under product code OLC
ApplicantClearances
Collagen Matrix, Inc1
Ivy Sports Medicine, LLC1
Regen Biologics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code