Champy Bone Plates & Bone Screws
FDA 510(k) K855030 · Advanced Biosearch Assn.
510(k) numberK855030
Submission
- Device name
- Champy Bone Plates & Bone Screws
- Applicant
- Advanced Biosearch Assn.
Rockville, MD, US - Received
- December 16, 1985
- Decision date
- January 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K905514 | Autogenesis(Tm) AutomatorKTT · Traditional | 04/02/1991SE |
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| K855031 | Manual Surgical Instruments & Access.Champy Bone PHWC · Traditional | 01/21/1986SE |
| 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 Champy Bone Plates & Bone Screws cleared by the FDA?
Champy Bone Plates & Bone Screws (K855030) received a 510(k) decision of Substantially Equivalent on January 30, 1986, 45 days after the submission was received.
What is the product code of K855030?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.