FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
K Number: K142488
·
Decision Dec 18, 2014
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
27
Review Days
105
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Basic Information
- Device Name
- SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
- K Number
- K142488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seaspine, Inc.
- Date Received
- September 4, 2014
- Decision Date
- December 18, 2014
- 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231654 | NorthStar OCT System | Aug 3, 2023 | Substantially Equivalent |
| K150469 | Integra Laminoplasty System | Mar 23, 2015 | Substantially Equivalent |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 1, 2014 | Substantially Equivalent |
| K132859 | INTEGRA FACET FIXATION SYSTEM | Nov 18, 2013 | Substantially Equivalent |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Sep 4, 2013 | Substantially Equivalent |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 | Substantially Equivalent |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | Dec 12, 2012 | Substantially Equivalent |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Jan 25, 2012 | Substantially Equivalent |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Dec 28, 2011 | Substantially Equivalent |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 | Substantially Equivalent |