FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Camber Spine Navigation System
K Number: K220038
·
Decision Apr 29, 2022
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
17
Review Days
114
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Basic Information
- Device Name
- Camber Spine Navigation System
- K Number
- K220038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Camber Spine Technologies
- Date Received
- January 5, 2022
- Decision Date
- April 29, 2022
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Camber Spine Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K234077 | SPIRA® Anterior Lumbar Spacers | Jul 12, 2024 | Substantially Equivalent |
| K233972 | Camber Sacroiliac (SI) Fixation System | Feb 27, 2024 | Substantially Equivalent |
| K230942 | SPIRA® Posterior Lumbar Spacers | Jul 11, 2023 | Substantially Equivalent |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Mar 30, 2023 | Substantially Equivalent |
| K223837 | SPIRA®-C Integrated Fixation System | Mar 22, 2023 | Substantially Equivalent |
| K193153 | SPIRA-C Integrated Fixation System | Apr 24, 2020 | Substantially Equivalent |
| K190483 | SPIRA Open Matrix ALIF and LLIF | Sep 23, 2019 | Substantially Equivalent |
| K173432 | ENZA-A Titanium ALIF | Apr 18, 2018 | Substantially Equivalent |
| K173800 | Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage | Feb 2, 2018 | Substantially Equivalent |
| K172446 | SPIRA-C Open Matrix Cervical Interbody | Nov 7, 2017 | Substantially Equivalent |