FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K Number: K071905
·
Decision Dec 28, 2007
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
13
Review Days
171
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Basic Information
- Device Name
- POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- K Number
- K071905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lanx, LLC
- Date Received
- July 10, 2007
- Decision Date
- December 28, 2007
- 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, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K120399 | LANX SPINAL FIXATION SYSTEM | Mar 9, 2012 | Substantially Equivalent |
| K102738 | LANX FUSION SYSTEM | Feb 10, 2011 | Substantially Equivalent |
| K103040 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Feb 8, 2011 | Substantially Equivalent |
| K093285 | MODIFICATION TO LANX SPINAL FIXATION SYSTEM | Dec 10, 2009 | Substantially Equivalent |
| K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Oct 21, 2008 | Substantially Equivalent |
| K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE | Jan 24, 2008 | Substantially Equivalent |
| K071877 | LANX SPINAL FIXATION SYSTEM | Sep 17, 2007 | Substantially Equivalent |
| K071633 | LANX DEFORMITY SYSTEM | Aug 15, 2007 | Substantially Equivalent |
| K052384 | LANX VBR SYSTEM | Oct 7, 2005 | Substantially Equivalent |
| K043484 | LANX SPINAL FIXATION SYSTEM | May 16, 2005 | Substantially Equivalent |