The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for Versaloop Anchor System.
| Device ID | K202178 |
| 510k Number | K202178 |
| Device Name: | VersaLoop Anchor System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Contact | Shlomi Dines |
| Correspondent | Anat Rozen T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2020-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818674025055 | K202178 | 000 |
| 10818674025048 | K202178 | 000 |
| 10818674024812 | K202178 | 000 |
| 10818674024805 | K202178 | 000 |
| 10818674024799 | K202178 | 000 |
| 10818674024782 | K202178 | 000 |
| 10818674024775 | K202178 | 000 |
| 10818674024768 | K202178 | 000 |
| 10818674024751 | K202178 | 000 |