FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
K Number: K092540
·
Decision Jan 27, 2010
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
7
Review Days
161
Basic Information
- Device Name
- C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
- K Number
- K092540
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rsb Spine, LLC
- Date Received
- August 19, 2009
- Decision Date
- January 27, 2010
- 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 Rsb Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K092070 | INTERPLATE C | Oct 6, 2009 | Substantially Equivalent |
| K081194 | INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) | May 29, 2008 | Substantially Equivalent |
| K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | Sep 18, 2007 | Substantially Equivalent |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | Jun 11, 2007 | Substantially Equivalent |
| K070316 | INTERPLATE VBR SYSTEM | Apr 19, 2007 | Substantially Equivalent |
| K061401 | INTERPLATE VBR SYSTEM | Aug 18, 2006 | Substantially Equivalent |