FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIMX SPINAL SYSTEMS
K Number: K013295
·
Decision Oct 9, 2001
Classifications
1
FEI Numbers
338
Registration Numbers
338
Same Product Code
308
Applicant Total
47
Review Days
7
Basic Information
- Device Name
- TIMX SPINAL SYSTEMS
- K Number
- K013295
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY ACROMED
- Date Received
- October 2, 2001
- Decision Date
- October 9, 2001
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K030249 | SURGICAL TITANIUM MESH SYSTEM | Feb 14, 2003 | Substantially Equivalent |
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| K023835 | DEVEX MESH SYSTEM | Jan 29, 2003 | Substantially Equivalent |
| K024348 | MONARCH SPINE SYSTEM | Jan 28, 2003 | Substantially Equivalent |
| K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT | Jan 23, 2003 | Substantially Equivalent |
| K023438 | MODIFICATION TO MONARCH SPINE SYSTEM | Nov 13, 2002 | Substantially Equivalent |