FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
K Number: K173606
·
Decision Apr 13, 2018
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
66
Review Days
143
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
- SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device
- K Number
- K173606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SeaSpine Orthopedics Corporation
- Date Received
- November 21, 2017
- Decision Date
- April 13, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVD), ordered by most recent decision date.
Anteralign LS coverplate
FDA 510(k)
FDA Class 2
·Orthopedic
MectaLIF 3D Metal Anterior
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana A Anterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DeGen Medical Patient Specific Implant (PSI) System
FDA 510(k)
FDA Class 2
·Orthopedic
IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by SeaSpine Orthopedics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250908 | Virata Spinal Fixation System | Jun 18, 2025 | Substantially Equivalent |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | Apr 2, 2025 | Substantially Equivalent |
| K242273 | Cove Putty, OsteoCove Putty | Sep 25, 2024 | Substantially Equivalent |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | Jun 20, 2024 | Substantially Equivalent |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | Apr 26, 2024 | Substantially Equivalent |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | Apr 19, 2024 | Substantially Equivalent |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | Jan 12, 2024 | Substantially Equivalent |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | Nov 28, 2023 | Substantially Equivalent |
| K232668 | Cove Strip, OsteoCove Strip | Sep 27, 2023 | Substantially Equivalent |
| K231030 | Cove Putty, OsteoCove Putty | Sep 14, 2023 | Substantially Equivalent |