FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K Number: K102020
·
Decision Sep 1, 2010
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
20
Review Days
44
Basic Information
- Device Name
- VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
- K Number
- K102020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPINEFRONTIER, INC.
- Date Received
- July 19, 2010
- Decision Date
- September 1, 2010
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by SPINEFRONTIER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K151198 | A-CIFT SoloFuse | Jul 17, 2015 | Substantially Equivalent |
| K143377 | PedFuse Pedicle Screw System | Feb 12, 2015 | Substantially Equivalent |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Nov 25, 2014 | Substantially Equivalent |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Oct 20, 2014 | Substantially Equivalent |
| K141337 | ARENA-C | Sep 8, 2014 | Substantially Equivalent |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | May 14, 2014 | Substantially Equivalent |
| K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM | Jan 3, 2014 | Substantially Equivalent |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | Nov 26, 2013 | Substantially Equivalent |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Feb 15, 2013 | Substantially Equivalent |
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM | Jul 3, 2012 | Substantially Equivalent |