FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES ANTEGRA SYSTEM
K Number: K063158
·
Decision Nov 14, 2006
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
18
Review Days
28
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
- SYNTHES ANTEGRA SYSTEM
- K Number
- K063158
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes Spine Co.Lp
- Date Received
- October 17, 2006
- Decision Date
- November 14, 2006
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
ARIES Anterior Cervical Plate Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
VyPlate Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ANTERIS Thoracolumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
PathLoc Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Synthes Spine Co.Lp
| K Number | Device Name | ||
|---|---|---|---|
| K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Jul 25, 2012 | Substantially Equivalent |
| K112459 | SYNTHES ZERO-P | Dec 12, 2011 | Substantially Equivalent |
| K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | Nov 7, 2011 | Substantially Equivalent |
| K103320 | SYNTHES XRL | Oct 20, 2011 | Substantially Equivalent |
| K081568 | ANTEGRA-T | Sep 2, 2008 | Substantially Equivalent |
| K080020 | ARCOFIX | May 23, 2008 | Substantially Equivalent |
| K072981 | SYNTHES ZERO-P | Feb 11, 2008 | Substantially Equivalent |
| K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS | Jan 10, 2008 | Substantially Equivalent |
| K072253 | SYNFIX-LR SPACER | Oct 12, 2007 | Substantially Equivalent |
| K070573 | SYNAPSE SYSTEM | Jun 8, 2007 | Substantially Equivalent |