FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SureMAX-SA Cervical Standalone System
K Number: K211111
·
Decision Jul 16, 2021
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
2
Review Days
93
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SureMAX-SA Cervical Standalone System
- K Number
- K211111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Additive Implants, Inc.
- Date Received
- April 14, 2021
- Decision Date
- July 16, 2021
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVE), ordered by most recent decision date.
CONDUIT ZERO-P VA Secured Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
NeckTune 3D SA Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
SABER-C System
FDA 510(k)
FDA Class 2
·Orthopedic
SAGI Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Uni-C Cervical Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
E3D-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Additive Implants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K193359 | SureMAX Family of Cervical Spacers | Jan 3, 2020 | Substantially Equivalent |