The following data is part of a premarket notification filed by Mtp Solutions Llc with the FDA for Titanium Suture Anchor.
Device ID | K133229 |
510k Number | K133229 |
Device Name: | TITANIUM SUTURE ANCHOR |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan, UT 84321 |
Contact | Robert Hoy |
Correspondent | Robert Hoy MTP SOLUTIONS LLC 124 SOUTH 600 WEST, SUITE 100 Logan, UT 84321 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-21 |
Decision Date | 2014-01-30 |
Summary: | summary |