FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K Number: K082821
·
Decision Oct 31, 2008
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
9
Review Days
36
Basic Information
- Device Name
- SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
- K Number
- K082821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPINE SMITH PARTNERS L.P.
- Date Received
- September 25, 2008
- Decision Date
- October 31, 2008
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by SPINE SMITH PARTNERS L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K122630 | IN:C2 SPINAL FIXATION SYSTEM | Dec 5, 2012 | Substantially Equivalent |
| K122168 | VISUALIF CHALLENGING ACCESS PLATE | Oct 11, 2012 | Substantially Equivalent |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | Jul 1, 2010 | Substantially Equivalent |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | Apr 1, 2009 | Substantially Equivalent |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Jul 14, 2008 | Substantially Equivalent |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Jul 2, 2008 | Substantially Equivalent |
| K073320 | CIMPLICITY SPINAL SYSTEM | Feb 7, 2008 | Substantially Equivalent |