FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Edge Upper Cervical System
K Number: K221307
·
Decision Jul 10, 2023
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
112
Applicant Total
11
Review Days
431
Basic Information
- Device Name
- Edge Upper Cervical System
- K Number
- K221307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Simplicity LLC
- Date Received
- May 5, 2022
- Decision Date
- July 10, 2023
- Product Code
- NKG
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Spinal Simplicity LLC
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|---|---|---|---|
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| K231923 | Liberty SI Lateral Implant System | Dec 5, 2023 | Substantially Equivalent |
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| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 | Aug 19, 2022 | Substantially Equivalent |
| K211880 | Minuteman G5 MIS Fusion Plate | Mar 11, 2022 | Substantially Equivalent |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate | Dec 15, 2021 | Substantially Equivalent |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Dec 10, 2020 | Substantially Equivalent |