FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LANX SPINAL FIXATION SYSTEM
K Number: K100935
·
Decision Aug 6, 2010
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
22
Review Days
123
Basic Information
- Device Name
- LANX SPINAL FIXATION SYSTEM
- K Number
- K100935
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LANX, INC.
- Date Received
- April 5, 2010
- Decision Date
- August 6, 2010
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by LANX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K131547 | LANX FUSION SYSTEM | Jul 12, 2013 | Substantially Equivalent |
| K131156 | LANX SPINAL FIXATION SYSTEM | May 24, 2013 | Substantially Equivalent |
| K123767 | LANX FUSION SYSTEM- SA | Mar 18, 2013 | Substantially Equivalent |
| K121316 | LANX SPINAL FIZATION SYSTEM | Sep 10, 2012 | Substantially Equivalent |
| K122145 | LANX SPINAL FIXATION SYSTEM | Aug 17, 2012 | Substantially Equivalent |
| K121940 | LANX SPINAL FIXATION SYSTEM | Aug 2, 2012 | Substantially Equivalent |
| K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Dec 19, 2011 | Substantially Equivalent |
| K103091 | LANX SPINAL FIXATION SYSTEM | Apr 15, 2011 | Substantially Equivalent |
| K103237 | LANX SPINAL SYSTEM | Mar 25, 2011 | Substantially Equivalent |
| K103666 | LANX LATERAL | Mar 23, 2011 | Substantially Equivalent |