FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CHAMELEON FIXATION SYSTEM
K Number: K071420
·
Decision Jan 16, 2008
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
24
Review Days
239
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Basic Information
- Device Name
- CHAMELEON FIXATION SYSTEM
- K Number
- K071420
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinefrontier, Inc.
- Date Received
- May 22, 2007
- Decision Date
- January 16, 2008
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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|---|---|---|---|
| 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 |