FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoreLink Navigation Instruments
K Number: K230880
·
Decision May 2, 2023
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
35
Review Days
33
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Basic Information
- Device Name
- CoreLink Navigation Instruments
- K Number
- K230880
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corelink, LLC
- Date Received
- March 30, 2023
- Decision Date
- May 2, 2023
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Corelink, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Dec 8, 2023 | Substantially Equivalent |
| K231494 | CoreLink Robotic Navigation Instruments | Oct 27, 2023 | Substantially Equivalent |
| K232116 | CoreLink Navigation Instruments | Aug 16, 2023 | Substantially Equivalent |
| K230329 | F3D Interbody System | Jun 6, 2023 | Substantially Equivalent |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Mar 21, 2023 | Substantially Equivalent |
| K221776 | NextGen Pedicle Screw System | Aug 9, 2022 | Substantially Equivalent |
| K220973 | CoreLink Navigation Instruments | Jun 1, 2022 | Substantially Equivalent |
| K211417 | F3D-C2 Cervical Stand-Alone System | Feb 4, 2022 | Substantially Equivalent |
| K214059 | CoreLink Navigation Instruments | Jan 19, 2022 | Substantially Equivalent |
| K212825 | CoreLink Navigation Instruments | Oct 13, 2021 | Substantially Equivalent |