FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoCentric Integrated Hip Fastener System
K Number: K230764
·
Decision Apr 18, 2023
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
22
Applicant Total
11
Review Days
29
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Basic Information
- Device Name
- OsteoCentric Integrated Hip Fastener System
- K Number
- K230764
- 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
- March 20, 2023
- Decision Date
- April 18, 2023
- Product Code
- JDO
- 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 |
|---|---|---|---|
| JDO | Device, Fixation, Proximal Femoral, Implant | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDO), ordered by most recent decision date.
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoCentric Integrated Hip Fastener System
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FDA Class 2
·Orthopedic
THP Hip Fracture Plating System
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CONQUEST FN
FDA 510(k)
FDA Class 2
·Orthopedic
CONQUEST FN
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K230595 | OsteoCentric ACL Fixation System | Jun 29, 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 |