FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIMPLICITY SPINAL SYSTEM
K Number: K073320
·
Decision Feb 7, 2008
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
9
Review Days
73
Basic Information
- Device Name
- CIMPLICITY SPINAL SYSTEM
- K Number
- K073320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Smith Partners L.P.
- Date Received
- November 26, 2007
- Decision Date
- February 7, 2008
- 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 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 |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | Oct 31, 2008 | 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 |