The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for Fiberstitch Implant, Curved With Two Polyester Implants And 2-0 Fiberwire, Fiberstitch Implant, Straight With Two Polyester Implants And 2-0 Fiberwire.
| Device ID | K221731 |
| 510k Number | K221731 |
| Device Name: | FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWire |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. Medical Products Corporation, Ltd Gaaton, IL 2513000 |
| Contact | Shlomi Dines |
| Correspondent | Shlomi Dines T.A.G. Medical Products Corporation, Ltd 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 | 2022-06-15 |
| Decision Date | 2022-09-07 |