FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SIGNEX
K Number: K230546
·
Decision Jun 11, 2024
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
20
Review Days
469
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Basic Information
- Device Name
- SIGNEX
- K Number
- K230546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteonic Co., Ltd.
- Date Received
- February 28, 2023
- Decision Date
- June 11, 2024
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Osteonic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K254182 | Aster | Feb 26, 2026 | Substantially Equivalent |
| K243469 | SIGNEX | May 29, 2025 | Substantially Equivalent |
| K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Dec 3, 2024 | Substantially Equivalent |
| K243470 | Fix2Lock (PEEK Self Punching) | Dec 3, 2024 | Substantially Equivalent |
| K233659 | Suture Wing | Dec 26, 2023 | Substantially Equivalent |
| K231322 | Fix2Lock(PEEK Self Punching) | Jun 7, 2023 | Substantially Equivalent |
| K231326 | Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) | May 31, 2023 | Substantially Equivalent |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) | Jan 27, 2022 | Substantially Equivalent |
| K211992 | Ortho MI System | Oct 15, 2021 | Substantially Equivalent |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Aug 27, 2021 | Substantially Equivalent |