FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoCentric ACL Fixation System
K Number: K230595
·
Decision Jun 29, 2023
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
11
Review Days
118
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Basic Information
- Device Name
- OsteoCentric ACL Fixation System
- K Number
- K230595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OsteoCentric Technologies
- Date Received
- March 3, 2023
- Decision Date
- June 29, 2023
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by OsteoCentric Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | Aug 16, 2025 | Substantially Equivalent |
| K250494 | The OsteoCentric Bone Plate and Screw System | Mar 18, 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 |
| 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 |