Fix2Lock(PEEK Self Punching)
FDA 510(k) K231322 · Osteonic Co., Ltd.
510(k) numberK231322
Submission
- Device name
- Fix2Lock(PEEK Self Punching)
- Applicant
- Osteonic Co., Ltd.
Seoul, KR - Received
- May 8, 2023
- Decision date
- June 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)MAI · Traditional | 08/27/2021SE |
Questions and answers
When was Fix2Lock(PEEK Self Punching) cleared by the FDA?
Fix2Lock(PEEK Self Punching) (K231322) received a 510(k) decision of Substantially Equivalent on June 7, 2023, 30 days after the submission was received.
What is the product code of K231322?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.