FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The OsteoCentric Bone Plate and Screw System
K Number: K250494
·
Decision Mar 18, 2025
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
11
Review Days
26
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Basic Information
- Device Name
- The OsteoCentric Bone Plate and Screw System
- K Number
- K250494
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OsteoCentric Technologies
- Date Received
- February 20, 2025
- Decision Date
- March 18, 2025
- 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
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
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 OsteoCentric Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | Aug 16, 2025 | Substantially Equivalent |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | Oct 9, 2024 | Substantially Equivalent |
| K230242 | OsteoCentric Dental Implant System | Oct 5, 2023 | Substantially Equivalent |
| K230226 | Integrity-SI® Fusion System | Sep 21, 2023 | Substantially Equivalent |
| K230595 | OsteoCentric ACL Fixation System | Jun 29, 2023 | Substantially Equivalent |
| K230764 | OsteoCentric Integrated Hip Fastener System | Apr 18, 2023 | Substantially Equivalent |
| K222512 | Integrity-SI Fusion System | Sep 12, 2022 | Substantially Equivalent |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | Jul 28, 2022 | Substantially Equivalent |
| K211290 | Cannulated Fasteners and Nuts | Aug 3, 2021 | Substantially Equivalent |
| K210754 | Cannulated Fasteners and Nuts | Apr 14, 2021 | Substantially Equivalent |