The following data is part of a premarket notification filed by Ivy Sports Medicine, Llc with the FDA for Ivyair Meniscus System, Curved, Ivyair Meniscus System, Straight, Ivyair Meniscus System, Reverse Curved.
| Device ID | K153087 |
| 510k Number | K153087 |
| Device Name: | IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327375404 | K153087 | 000 |
| 07613327482065 | K153087 | 000 |
| 07613327482072 | K153087 | 000 |