FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA LAMINOPLASTY SYSTEM
K Number: K130830
·
Decision May 9, 2013
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
29
Applicant Total
27
Review Days
44
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
- INTEGRA LAMINOPLASTY SYSTEM
- K Number
- K130830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seaspine, Inc.
- Date Received
- March 26, 2013
- Decision Date
- May 9, 2013
- Product Code
- NQW
- 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 |
|---|---|---|---|
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQW), ordered by most recent decision date.
AQUA Laminoplasty Systems
FDA 510(k)
FDA Class 2
·Orthopedic
Curiteva Porous PEEK Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Vy Spine VyLam Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Vy Spine VyLam Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Curiteva Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Centerpiece Plate Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | Dec 18, 2014 | 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 |
| 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 |