Minilok Quickanchor Plus
FDA 510(k) K030995 · Mitek Worldwide
510(k) numberK030995
Submission
- Device name
- Minilok Quickanchor Plus
- Applicant
- Mitek Worldwide
Norwood, MA, US - Received
- March 31, 2003
- Decision date
- June 26, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K032717 | Biocryl Rapide Interference ScrewHWC · Traditional | 03/31/2004SE |
| K032167 | Bio-Intrafix Tibial Screw and SheathHWC · Traditional | 10/15/2003SE |
| K032078 | Mitek Micro QuickanchorNOV · Traditional | 08/25/2003SE |
| K031519 | Cufflok AnchorMAI · Special | 06/06/2003SE |
| K031406 | Exojet Tissue Management SystemHRX · Traditional | 05/30/2003SE |
| K024115 | Microfix Quickanchor PlusHWC · Traditional | 03/13/2003SE |
| K023388 | Mitek Rapidloc-Pds Meniscal Repair SystemJDR · Special | 12/27/2002SE |
| K021953 | Mitek Pds/Pga StapleJDR · Traditional | 12/20/2002SE |
| K021883 | Biofastin RC Threaded Suture AnchorHWC · Special | 07/01/2002SE |
Questions and answers
When was Minilok Quickanchor Plus cleared by the FDA?
Minilok Quickanchor Plus (K030995) received a 510(k) decision of Substantially Equivalent on June 26, 2003, 87 days after the submission was received.
What is the product code of K030995?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.