The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd. with the FDA for Knotilus Anchor System.
| Device ID | K113297 |
| 510k Number | K113297 |
| Device Name: | KNOTILUS ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30810190010014 | K113297 | 000 |
| 30810190010007 | K113297 | 000 |