The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for G-lok And G-lok Xl Extender.
| Device ID | K142653 |
| 510k Number | K142653 |
| Device Name: | G-Lok And G-Lok XL Extender |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. Medical Products Corporation, Ltd D.N. Ashrat Kibbutz Gaaton, IL 25130 |
| Contact | Tomer Alon |
| Correspondent | George J Hattub MedicSense, USA 291 HILLSIDE AVENUE Somerset,, MA 02726 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-18 |
| Decision Date | 2014-10-16 |
| Summary: | summary |