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
321
Registration Numbers
321
Same Product Code
429
Applicant Total
24
Review Days
44
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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 | ||
|---|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Jun 19, 2020 | Substantially Equivalent |
| K172484 | A-CIFT SoloFuse | May 8, 2018 | Substantially Equivalent |
| K151198 | A-CIFT SoloFuse | Jul 17, 2015 | Substantially Equivalent |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | May 13, 2015 | Substantially Equivalent |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | Apr 24, 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 |