FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Altus Spine Navigation System
K Number: K243419
·
Decision May 8, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
17
Review Days
185
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Basic Information
- Device Name
- Altus Spine Navigation System
- K Number
- K243419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Altus Partners, LLC
- Date Received
- November 4, 2024
- Decision Date
- May 8, 2025
- 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 Altus Partners, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K211027 | Altus Spine Pedicle Screw System | Sep 16, 2022 | Substantially Equivalent |
| K211837 | Altus Spine Interbody Standalone Fusion System | Apr 19, 2022 | Substantially Equivalent |
| K210887 | Altus Spine Sochi OCT Spinal System | Aug 20, 2021 | Substantially Equivalent |
| K200922 | Altus Spine HA Pedicle Screw System | Jan 26, 2021 | Substantially Equivalent |
| K200322 | Altus Spine Pedicle Screw System | Jun 2, 2020 | Substantially Equivalent |
| K183084 | Fuji Cervical Plate System | May 29, 2019 | Substantially Equivalent |
| K182406 | Altus Spine Interbody Fusion System | Feb 22, 2019 | Substantially Equivalent |
| K181339 | Altus Spine Pedicle Screw System | Jul 24, 2018 | Substantially Equivalent |
| K181281 | Altus Spine Pedicle Screw System | Jun 11, 2018 | Substantially Equivalent |
| K170553 | Altus Spine Interbody Fusion System | Dec 1, 2017 | Substantially Equivalent |