FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OUTOLOGOUS SPINAL FIXATION SYSTEM
K Number: K040493
·
Decision Sep 3, 2004
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
11
Review Days
190
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Basic Information
- Device Name
- OUTOLOGOUS SPINAL FIXATION SYSTEM
- K Number
- K040493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopedic Sciences, Inc.
- Date Received
- February 26, 2004
- Decision Date
- September 3, 2004
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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| K063709 | TS-BONE HIP TOOL | Jan 4, 2007 | Substantially Equivalent |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | Nov 1, 2006 | Substantially Equivalent |
| K052538 | S-BONE HIP TOOL | Oct 7, 2005 | Substantially Equivalent |
| K051032 | TITANIUM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K051181 | CUSTOM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K040850 | TSY SHOULDER PLATE IMPLANT | Jun 24, 2004 | Substantially Equivalent |
| K022139 | HIP TOOL IMPLANT | Sep 23, 2002 | Substantially Equivalent |