FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
K Number: K122049
·
Decision Apr 5, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
33
Review Days
267
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
- NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
- K Number
- K122049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinamed, Inc.
- Date Received
- July 12, 2012
- Decision Date
- April 5, 2013
- Product Code
- GWO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWO), ordered by most recent decision date.
TECHFIT Patient-Specific Cranial System
FDA 510(k)
FDA Class 2
·Neurology
Fusion Craniofacial Implant; Fusion Skull Implant
FDA 510(k)
FDA Class 2
·Neurology
VSP PEEK Cranial Implant
FDA 510(k)
FDA Class 2
·Neurology
MCI-Neuro Fixation System
FDA 510(k)
FDA Class 2
·Neurology
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
FDA 510(k)
FDA Class 2
·Neurology
Stryker PEEK Customized Cranial Implant Kit
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Kinamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | Nov 9, 2007 | Substantially Equivalent |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | May 24, 2005 | Substantially Equivalent |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Mar 11, 2004 | Substantially Equivalent |
| K032950 | GEM INSET PATELLAR COMPONENT | Dec 19, 2003 | Substantially Equivalent |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Oct 21, 2003 | Substantially Equivalent |
| K020764 | NAVIPRO | Jun 3, 2002 | Substantially Equivalent |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | May 21, 2002 | Substantially Equivalent |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | May 17, 2001 | Substantially Equivalent |
| K003347 | ORTHOPILOT | Feb 23, 2001 | Substantially Equivalent |
| K994214 | GEM KNEE SYSTEM | Jul 19, 2000 | Substantially Equivalent |