FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lateral Plate System
K Number: K190016
·
Decision Jun 12, 2019
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
35
Review Days
160
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Basic Information
- Device Name
- Lateral Plate System
- K Number
- K190016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corelink, LLC
- Date Received
- January 3, 2019
- Decision Date
- June 12, 2019
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Corelink, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K232116 | CoreLink Navigation Instruments | Aug 16, 2023 | Substantially Equivalent |
| K230329 | F3D Interbody System | Jun 6, 2023 | Substantially Equivalent |
| K230880 | CoreLink Navigation Instruments | May 2, 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 |