FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pisces-SA STANDALONE ALIF Interbody System
K Number: K223413
·
Decision Feb 10, 2023
Classifications
1
FEI Numbers
254
Registration Numbers
254
Same Product Code
194
Applicant Total
5
Review Days
93
Basic Information
- Device Name
- Pisces-SA STANDALONE ALIF Interbody System
- K Number
- K223413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osseus Fusion Systems
- Date Received
- November 9, 2022
- Decision Date
- February 10, 2023
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Osseus Fusion Systems
| K Number | Device Name | ||
|---|---|---|---|
| K222107 | Black Diamond POCT Spinal System | Nov 3, 2022 | Substantially Equivalent |
| K213935 | PISCES-SA Standalone ALIF Interbody System | May 6, 2022 | Substantially Equivalent |
| K192495 | Black Diamond Navigation Instruments | Jan 17, 2020 | Substantially Equivalent |
| K192121 | Black Diamond Pedicle Screw System | Oct 29, 2019 | Substantially Equivalent |