Mitek Products
Medical device manufacturer in Norwood, MA.
30510(k) clearances
0PMA approvals
0recalls
Device types
- MBI Fastener, Fixation, Nondegradable, Soft… 7
- GEI Electrosurgical, Cutting & Coagulation &… 4
- HWC Screw, Fixation, Bone 4
- MAI Fastener, Fixation, Biodegradable, Soft… 3
- HTY Pin, Fixation, Smooth 3
- DZL Screw, Fixation, Intraosseous 3
- JDR Staple, Fixation, Bone 2
- HRX Arthroscope 2
- HWQ Passer 1
- GAM Suture, Absorbable, Synthetic, Polyglycolic… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K013572 | Mitek Biocryl Interference ScrewsHWC · Special | 03/14/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | 02/06/2002SE |
| K002639 | Bioknotless AnchorGAM · Traditional | 05/11/2001SE |
| K010633 | Rigidfix Soft Tissue Acl Crosspin SystemHWC · Traditional | 05/09/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | 02/15/2001SE |
| K003076 | Mitek CufftackMAI · Special | 10/27/2000SE |
| K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemGEI · Special | 08/31/2000SE |
| K002402 | Vapr TC Electrode for Use with Vapr II Electrosurgical SystemHRX · Special | 08/31/2000SE |
| K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemGEI · Special | 04/19/2000SE |
| K993575 | Resolve QuickanchorDZL · Traditional | 12/29/1999SE |
| K993327 | Talon Anchor Snap-PakDZL · Traditional | 12/16/1999SE |
| K993261 | Talon Anchor Snap-PakMBI · Traditional | 12/02/1999SE |
| K992623 | Mitek Mini AnchorDZL · Traditional | 11/02/1999SE |
| K992876 | Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemHRX · Special | 09/24/1999SE |
| K992611 | Mitek Rotator Cuff Quickanchor PlusHWC · Traditional | 09/22/1999SE |
| K992487 | Mitek Mini Quickanchor PlusHWC · Traditional | 09/21/1999SE |
| K992406 | Vapr 2.3MM End Effect Electrode for Use with Vapr SystemGEI · Special | 08/06/1999SE |
| K983818 | Mitek Fastin RC AnchorMBI · Special | 11/23/1998SE |
| K982420 | Mitek Micro AnchorJDR · Traditional | 08/24/1998SE |
| K974341 | Mitek BTB Absorbable (Pla) Cross PinHTY · Traditional | 04/16/1998SE |
| K974291 | Mitek BTB Absorbable (Pla) Cross PinHTY · Traditional | 03/05/1998SE |
| K974345 | Mitek Knotless AnchorMBI · Traditional | 02/13/1998SE |
| K970119 | Mitek Absorbable Polydioxanone (PDS) H FixMBI · Traditional | 01/30/1998SE |
| K974022 | VaprGEI · Traditional | 01/12/1998SE |
| K973009 | Mitek Non Absorbable Polypropylene H FixMBI · Traditional | 11/10/1997SE |
| K970360 | Mitek Suture RetrograderHWQ · Traditional | 03/10/1997SE |
| K964013 | Mitek Absorbable Toggle AnchorMAI · Traditional | 02/24/1997SE |
| K962511 | Mitek Micro AnchorMBI · Traditional | 11/06/1996SE |
| K961094 | Mitek Threaded Anchor (Modification)MBI · Traditional | 10/03/1996SE |
| K962793 | Mitek Micro AnchorJDR · Traditional | 10/01/1996SE |