FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Altus Spine Interbody Fusion System
K Number: K170553
·
Decision Dec 1, 2017
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
17
Review Days
280
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Basic Information
- Device Name
- Altus Spine Interbody Fusion System
- K Number
- K170553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Altus Partners, LLC
- Date Received
- February 24, 2017
- Decision Date
- December 1, 2017
- 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 Altus Partners, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K243419 | Altus Spine Navigation System | May 8, 2025 | Substantially Equivalent |
| 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 |