FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARDIS SPACER
K Number: K073202
·
Decision Jan 30, 2008
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
13
Review Days
78
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Basic Information
- Device Name
- ARDIS SPACER
- K Number
- K073202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Spine, Inc.
- Date Received
- November 13, 2007
- Decision Date
- January 30, 2008
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Abbott Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | Jun 2, 2009 | Substantially Equivalent |
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) | Oct 6, 2008 | Substantially Equivalent |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Aug 29, 2008 | Substantially Equivalent |
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | Nov 28, 2007 | Substantially Equivalent |
| K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS | Jul 25, 2007 | Substantially Equivalent |
| K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES | Sep 26, 2006 | Substantially Equivalent |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES | Mar 31, 2006 | Substantially Equivalent |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Mar 6, 2006 | Substantially Equivalent |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY | Jan 6, 2006 | Substantially Equivalent |
| K052638 | ABBOTT SPINE, INC. SPINNAKER SYSTEM | Nov 7, 2005 | Substantially Equivalent |