Mitek Giii Anchor
FDA 510(k) K931782 · Mitek Surgical Products, Inc.
510(k) numberK931782
Submission
- Device name
- Mitek Giii Anchor
- Applicant
- Mitek Surgical Products, Inc.
Norwood, MA, US - Received
- April 9, 1993
- Decision date
- July 22, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| K950070 | Mitek Toggle Anchor(Tm)JDR · Traditional | 05/22/1995SE |
| 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 |
| K931253 | Quickanchor IIJDR · Traditional | 06/16/1994SE |
Questions and answers
When was Mitek Giii Anchor cleared by the FDA?
Mitek Giii Anchor (K931782) received a 510(k) decision of Substantially Equivalent for Some Indications on July 22, 1994, 469 days after the submission was received.
What is the product code of K931782?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.