Depuy Set Screw
FDA 510(k) K950833 · Depuy, Inc.
510(k) numberK950833
Submission
- Device name
- Depuy Set Screw
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- February 24, 1995
- Decision date
- July 10, 1995
- 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
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| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
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| 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 |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
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Questions and answers
When was Depuy Set Screw cleared by the FDA?
Depuy Set Screw (K950833) received a 510(k) decision of Substantially Equivalent on July 10, 1995, 136 days after the submission was received.
What is the product code of K950833?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.