The following data is part of a premarket notification filed by Arcuro Medical Ltd. with the FDA for Superball Meniscal Repair System.
| Device ID | K180191 |
| 510k Number | K180191 |
| Device Name: | SuperBall Meniscal Repair System |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Arcuro Medical Ltd. 17 Tchelet St. Misgav, IL 2017400 |
| Contact | Lee Ranon |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850000630017 | K180191 | 000 |