Sterile bone screw (PEEK ACL screw)
FDA 510(k) K202883 · Osteonic Co., Ltd.
510(k) numberK202883
Submission
- Device name
- Sterile bone screw (PEEK ACL screw)
- Applicant
- Osteonic Co., Ltd.
Guro-Gu, KR - Received
- September 28, 2020
- Decision date
- November 25, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254182 | AsterKWQ · Traditional | 02/26/2026SE |
| K243469 | SignexHRS · Traditional | 05/29/2025SE |
| K243470 | Fix2Lock (PEEK Self Punching)MBI · Special | 12/03/2024SE |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)MAI · Special | 12/03/2024SE |
| K230546 | SignexHRS · Traditional | 06/11/2024SE |
| K233659 | Suture WingMBI · Special | 12/26/2023SE |
| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)MAI · Special | 05/31/2023SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | 01/27/2022SE |
| K211992 | Ortho MI SystemOAT · Traditional | 10/15/2021SE |
Questions and answers
When was Sterile bone screw (PEEK ACL screw) cleared by the FDA?
Sterile bone screw (PEEK ACL screw) (K202883) received a 510(k) decision of Substantially Equivalent on November 25, 2020, 58 days after the submission was received.
What is the product code of K202883?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.