Mli Interference Screw
FDA 510(k) K953350 · Medicinelodge, Inc.
510(k) numberK953350
Submission
- Device name
- Mli Interference Screw
- Applicant
- Medicinelodge, Inc.
Logan, UT, US - Received
- July 17, 1995
- Decision date
- January 30, 1996
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K072525 | Zipknot, Model 1017-3000FZP · Special | 10/05/2007SE |
| K051488 | Medicinelodge ZipknotNVH · Traditional | 07/27/2005SE |
| K962705 | Mli Modular StapleJDR · Traditional | 10/01/1996SE |
| K961920 | Cross PinJDW · Traditional | 09/17/1996SE |
| K961905 | Medicinelodge, Inc. Set ScrewHWC · Traditional | 08/06/1996SE |
| K962194 | Mli Soft Tissue Screw & Washer SystemMBI · Traditional | 07/30/1996SE |
| K961025 | Expanded Body SutureGAT · Traditional | 04/15/1996SN |
Questions and answers
When was Mli Interference Screw cleared by the FDA?
Mli Interference Screw (K953350) received a 510(k) decision of Substantially Equivalent for Some Indications on January 30, 1996, 197 days after the submission was received.
What is the product code of K953350?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.