MINNE TIES MMF Suture System
FDA 510(k) K162046 · Summit Medical, Inc.
510(k) numberK162046
Submission
- Device name
- MINNE TIES MMF Suture System
- Applicant
- Summit Medical, Inc.
St. Paul, MN, US - Received
- July 25, 2016
- Decision date
- April 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061271 | Erch Arch Bar, Model 38-690-00DYX · Traditional | KLS-Martin L.P. | 06/30/2006SE |
| K031207 | Safety Release Arch Bar KitDYX · Traditional | Casey Surgical, LLC | 07/15/2003SE |
| K030605 | Rapid ImfDYX · Traditional | Zygomatics , Ltd. | 06/27/2003SE |
| K990212 | Lockjaw 15 Minute Intermaxillary Fixation System,Model LJ100-00DYX · Traditional | Doctor'S Research Group, Inc. | 09/14/1999SE |
| K991004 | Synthes Quick Lock Imf SystemDYX · Traditional | Synthes (Usa) | 06/23/1999SE |
| K925106 | Implantable Pulse GeneratorsDYX · Traditional | Medtronic Vascular | 10/06/1993SE |
| K925712 | Reliance Short Stick TieDYX · Traditional | Reliance Orthodontic Products, Inc. | 01/11/1993SE |
| K910090 | Dimac WiresDYX · Traditional | Instrumentations Unltd. | 07/25/1991SE |
| K863799 | Jaw Fixation AssemblyDYX · Traditional | Medical Products & Research, Inc. | 10/14/1986SE |
| K820944 | Dental Arch BarDYX · Traditional | Unisplint Corp. | 05/05/1982SE |
More from Unisplint Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K180528 | InstruSafe(R) Sterilization ContainerKCT · Traditional | 11/16/2018SE |
| K173110 | GraftsiteBSP · Traditional | 05/18/2018SE |
| K170388 | ANCHORMAN Tibial Ligament Fixation DeviceMBI · Traditional | 07/25/2017SE |
| K151166 | Instru-Safe Instrument Protection SystemKCT · Traditional | 08/18/2015SE |
| K150540 | Instru-Safe Instrument Protection SystemKCT · Traditional | 06/22/2015SE |
| K142768 | Instru-Safe Instrument Protection SystemKCT · Traditional | 05/29/2015SE |
| K142630 | Instru-Safe Instrument Protection SystemKCT · Traditional | 12/23/2014SE |
| K141513 | Instru-Safe Instrument Protection SystemKCT · Traditional | 12/15/2014SE |
| K140289 | Instru-Safe Instrument Protection SystemKCT · Traditional | 06/27/2014SE |
| K133015 | Instru-Safe Instrument Protection SystemKCT · Traditional | 03/13/2014SE |
Questions and answers
When was MINNE TIES MMF Suture System cleared by the FDA?
MINNE TIES MMF Suture System (K162046) received a 510(k) decision of Substantially Equivalent on April 11, 2017, 260 days after the submission was received.
What is the product code of K162046?
The FDA product code is DYX – Lock, Wire, And Ligature, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.4600.