FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
nvc
K Number: K142328
·
Decision Dec 23, 2014
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
10
Review Days
125
Basic Information
- Device Name
- nvc
- K Number
- K142328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nvision Biomedical Technologies, LLC
- Date Received
- August 20, 2014
- Decision Date
- December 23, 2014
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Nvision Biomedical Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K182943 | VERTEX Nitinol Staple System | Apr 4, 2019 | Substantially Equivalent |
| K183055 | Vector Hammertoe Correction System | Feb 19, 2019 | Substantially Equivalent |
| K182949 | Healix Compression Screw System | Dec 4, 2018 | Substantially Equivalent |
| K180458 | FOCUS Pedicle Screw System | Apr 17, 2018 | Substantially Equivalent |
| K173091 | Boundary Anterior Lumbar Buttress Plate | Dec 6, 2017 | Substantially Equivalent |
| K170074 | nvc | Jan 24, 2017 | Substantially Equivalent |
| K162426 | nva, nvp, and nvt | Sep 29, 2016 | Substantially Equivalent |
| K161524 | Tangis Anterior Cervical Plate | Sep 2, 2016 | Substantially Equivalent |
| K142594 | nva, nvp, nvt | Nov 28, 2014 | Substantially Equivalent |