FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LANX ANTERIOR PLATING SYSTEM
K Number: K092765
·
Decision Apr 7, 2010
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
23
Review Days
210
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Basic Information
- Device Name
- LANX ANTERIOR PLATING SYSTEM
- K Number
- K092765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lanx, Inc.
- Date Received
- September 9, 2009
- Decision Date
- April 7, 2010
- 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 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 |
| K112388 | LANX CERVICAL SA | Dec 16, 2011 | Substantially Equivalent |
| K103091 | LANX SPINAL FIXATION SYSTEM | Apr 15, 2011 | Substantially Equivalent |
| K103237 | LANX SPINAL SYSTEM | Mar 25, 2011 | Substantially Equivalent |