The following data is part of a premarket notification filed by Ivy Sports Medicine, Llc with the FDA for Collagen Meniscus Implant Xl.
| Device ID | K170364 |
| 510k Number | K170364 |
| Device Name: | Collagen Meniscus Implant XL |
| Classification | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Resorbable Bovine Collagen |
| Applicant | Ivy Sports Medicine, LLC 545 Penobscot Drive Redwood City, CA 94063 |
| Contact | John Dichiara |
| Correspondent | John Dichiara Ivy Sports Medicine, LLC 545 Penobscot Drive Redwood City, CA 94063 |
| Product Code | OLC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-05-02 |
| Summary: | summary |