FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANS1 AXIALIF PLUS
K Number: K102334
·
Decision Mar 14, 2011
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
9
Review Days
209
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
- TRANS1 AXIALIF PLUS
- K Number
- K102334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trans1 Incorporated
- Date Received
- August 17, 2010
- Decision Date
- March 14, 2011
- 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 Trans1 Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K120991 | TRANS1 INTERBODY FUSION SYSTEM | Aug 23, 2012 | Substantially Equivalent |
| K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | Aug 26, 2010 | Substantially Equivalent |
| K092124 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II | Jan 21, 2010 | Substantially Equivalent |
| K073643 | TRANS1 AXIALIF 2-LEVEL OR II SYSTEM | Apr 28, 2008 | Substantially Equivalent |
| K073515 | TRANS1 FACET SCREW | Mar 11, 2008 | Substantially Equivalent |
| K073514 | TRANS1 AXIAL FIXATON SYSTEM | Jan 11, 2008 | Substantially Equivalent |
| K051856 | TRANS1 FACET SCREWS | Sep 26, 2005 | Substantially Equivalent |
| K050965 | TRANS1 AXIALIF SYSTEM | Jun 14, 2005 | Substantially Equivalent |