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 |