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 |