FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K Number: K081622
·
Decision Aug 29, 2008
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
13
Review Days
80
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Basic Information
- Device Name
- UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
- K Number
- K081622
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Spine, Inc.
- Date Received
- June 10, 2008
- Decision Date
- August 29, 2008
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | Nov 28, 2007 | Substantially Equivalent |
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| 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 |