Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer
FDA 510(k) K934366 · Mitek Surgical Products, Inc.
510(k) numberK934366
Submission
- Device name
- Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer
- Applicant
- Mitek Surgical Products, Inc.
Norwood, MA, US - Received
- September 7, 1993
- Decision date
- October 7, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 |
| K931782 | Mitek Giii AnchorJDR · Traditional | 07/22/1994SN |
| K931253 | Quickanchor IIJDR · Traditional | 06/16/1994SE |
Questions and answers
When was Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer cleared by the FDA?
Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer (K934366) received a 510(k) decision of Substantially Equivalent for Some Indications on October 7, 1994, 395 days after the submission was received.
What is the product code of K934366?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.