Manual Surgical Instruments & Access.Champy Bone P
FDA 510(k) K855031 · Advanced Biosearch Assn.
510(k) numberK855031
Submission
- Device name
- Manual Surgical Instruments & Access.Champy Bone P
- Applicant
- Advanced Biosearch Assn.
Rockville, MD, US - Received
- December 16, 1985
- Decision date
- January 21, 1986
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K905514 | Autogenesis(Tm) AutomatorKTT · Traditional | 04/02/1991SE |
| K883888 | Cathscanner Intravascular Ultrasonic Imaging Syst.DXK · Traditional | 12/12/1988SE |
| K854770 | Martin Laminar Osteosynthesis SystemKWP · Traditional | 02/11/1986SE |
| K855030 | Champy Bone Plates & Bone ScrewsJEY · Traditional | 01/30/1986SE |
| K853916 | P.M. Hip-Femoral ProsthesisJDI · Traditional | 12/27/1985SE |
| K852839 | Freeman HipJDI · Traditional | 10/29/1985SE |
| K853418 | Safti-BraceletKMK · Traditional | 09/20/1985SE |
| K852517 | CLS Hip ProsthesisJDI · Traditional | 09/18/1985SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | 09/05/1985SE |
| K850773 | PM Cementless Screw-In Acetabular CupKWA · Traditional | 05/02/1985SE |
Questions and answers
When was Manual Surgical Instruments & Access.Champy Bone P cleared by the FDA?
Manual Surgical Instruments & Access.Champy Bone P (K855031) received a 510(k) decision of Substantially Equivalent on January 21, 1986, 36 days after the submission was received.
What is the product code of K855031?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.