Mitek Toggle Anchor(Tm)
FDA 510(k) K950070 · Mitek Surgical Products, Inc.
510(k) numberK950070
Submission
- Device name
- Mitek Toggle Anchor(Tm)
- Applicant
- Mitek Surgical Products, Inc.
Westwood, MA, US - Received
- January 9, 1995
- Decision date
- May 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K953560 | Mitek Threaded Anchor (Fastin)MBI · Traditional | 01/31/1996SN |
| K953877 | Mitek Gii AnchorMBI · Traditional | 12/29/1995SE |
| K936311 | Mitek Mini AnchorMNV · Traditional | 10/31/1995SN |
| K941599 | Mitek Absorbable AnchorMNV · Traditional | 10/24/1995SN |
| K944051 | Absorbalbe AnchorMNV · Traditional | 08/02/1995SE |
| K944936 | Mitek G III Anchor, Mitek LS AnchorJDR · Traditional | 03/24/1995SE |
| K945203 | Mitek Thraded Anchor (Mta)JDR · Traditional | 03/06/1995SE |
| K934366 | Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue WasherHWC · Traditional | 10/07/1994SN |
| K931782 | Mitek Giii AnchorJDR · Traditional | 07/22/1994SN |
| K931253 | Quickanchor IIJDR · Traditional | 06/16/1994SE |
Questions and answers
When was Mitek Toggle Anchor(Tm) cleared by the FDA?
Mitek Toggle Anchor(Tm) (K950070) received a 510(k) decision of Substantially Equivalent on May 22, 1995, 133 days after the submission was received.
What is the product code of K950070?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.