FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K Number: K142026
·
Decision Oct 20, 2014
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
24
Review Days
87
Basic Information
- Device Name
- SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
- K Number
- K142026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinefrontier, Inc.
- Date Received
- July 25, 2014
- Decision Date
- October 20, 2014
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 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 |
| 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 |