FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
K Number: K210595
·
Decision Jun 15, 2021
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
6
Review Days
106
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Basic Information
- Device Name
- SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
- K Number
- K210595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Camber Spine Technologies, LLC
- Date Received
- March 1, 2021
- Decision Date
- June 15, 2021
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Camber Spine Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K232256 | Alcantara Thoracolumbar Plate System | Apr 16, 2024 | Substantially Equivalent |
| K203503 | Camber Sacroiliac (SI) Fixation System | Sep 2, 2022 | Substantially Equivalent |
| K191584 | FORTICO Anterior Cervical Fixation System | Oct 22, 2019 | Substantially Equivalent |
| K180980 | ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System | Oct 27, 2018 | Substantially Equivalent |
| K180724 | SPIRA Open Matrix LLIF | Jun 25, 2018 | Substantially Equivalent |