OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen Class II
FDA product code OLC covers "Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OLC
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.