FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
K Number: K151064
·
Decision Aug 12, 2015
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
19
Review Days
114
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Basic Information
- Device Name
- Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
- K Number
- K151064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Spine
- Date Received
- April 20, 2015
- Decision Date
- August 12, 2015
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Biomet Spine
| K Number | Device Name | ||
|---|---|---|---|
| K152622 | Alta ACDF System | Jul 8, 2016 | Substantially Equivalent |
| K151974 | Polaris Spinal System | Nov 13, 2015 | Substantially Equivalent |
| K151224 | Lineum OCT Spine System | Jun 30, 2015 | Substantially Equivalent |
| K141791 | BIOMET FUSION SYSTEM | Oct 9, 2014 | Substantially Equivalent |
| K121130 | POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS | Jun 15, 2012 | Substantially Equivalent |
| K112014 | ZYSTON STRAIGHT SPACER SYSTEM | Oct 17, 2011 | Substantially Equivalent |
| K103393 | POLARIS SPINAL SYSTEM | Feb 2, 2011 | Substantially Equivalent |
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM | Mar 9, 2010 | Substantially Equivalent |
| K091067 | 5.5 POLARIS SPINAL SYSTEM | Jul 14, 2009 | Substantially Equivalent |
| K082793 | INTERGRO DBM | Apr 2, 2009 | Substantially Equivalent |