Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
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 yearShow the numbers
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2017 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code OLC| Applicant | Clearances |
|---|---|
| Collagen Matrix, Inc | 1 |
| Ivy Sports Medicine, LLC | 1 |
| Regen Biologics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
