FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-PAC® N-GAGE Lumbar Plate System
K Number: K250602
·
Decision May 20, 2025
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
8
Review Days
81
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Basic Information
- Device Name
- X-PAC® N-GAGE Lumbar Plate System
- K Number
- K250602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Expanding Innovations, Inc.
- Date Received
- February 28, 2025
- Decision Date
- May 20, 2025
- 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 Expanding Innovations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Jun 25, 2025 | Substantially Equivalent |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Jun 16, 2025 | Substantially Equivalent |
| K223174 | X-Pac Expandable LLIF Cage System | Feb 14, 2023 | Substantially Equivalent |
| K222797 | X-Pac Expandable Lumbar Cage System | Oct 14, 2022 | Substantially Equivalent |
| K220655 | X-Pac Expandable Lumbar Cage System | Mar 24, 2022 | Substantially Equivalent |
| K203802 | X-Pac Expandable Lumbar Cage System | Jun 7, 2021 | Substantially Equivalent |
| K201145 | X-Pac Expandable Lumbar Cage System | Sep 10, 2020 | Substantially Equivalent |