FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
K Number: K162715
·
Decision Oct 28, 2016
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
62
Review Days
29
Basic Information
- Device Name
- SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
- K Number
- K162715
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SeaSpine Orthopedics Corporation
- Date Received
- September 29, 2016
- Decision Date
- October 28, 2016
- 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 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 |