Plus Cancellous Bone Screws
FDA 510(k) K011719 · Plus Orthopedics
510(k) numberK011719
Submission
- Device name
- Plus Cancellous Bone Screws
- Applicant
- Plus Orthopedics
San Diego, CA, US - Received
- June 4, 2001
- Decision date
- July 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
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| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
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| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| K032126 | Promos ShoulderHSD · Traditional | 01/08/2004SE |
| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
| K032709 | Modular Plus Hip StemLWJ · Special | 09/23/2003SE |
| K032548 | Ip-Xs Compression Nail SystemHSB · Traditional | 09/10/2003SE |
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Questions and answers
When was Plus Cancellous Bone Screws cleared by the FDA?
Plus Cancellous Bone Screws (K011719) received a 510(k) decision of Substantially Equivalent on July 2, 2001, 28 days after the submission was received.
What is the product code of K011719?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.