FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K Number: K223719
·
Decision Jan 11, 2023
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
- K Number
- K223719
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aegis Spine, Inc.
- Date Received
- December 12, 2022
- Decision Date
- January 11, 2023
- 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 Aegis Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223521 | ZESPIN SI Joint Fusion System | Jan 20, 2023 | Substantially Equivalent |
| K221719 | ABTross ALIF Expandable Cage System | Nov 3, 2022 | Substantially Equivalent |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | Jun 30, 2022 | Substantially Equivalent |
| K203531 | XYPAN Expandable Lumbar Cage System | Jan 29, 2021 | Substantially Equivalent |