FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOBAR SPINAL SYSTEM
K Number: K013440
·
Decision Nov 16, 2001
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- ISOBAR SPINAL SYSTEM
- K Number
- K013440
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scien'Tx USA, Inc.
- Date Received
- October 17, 2001
- Decision Date
- November 16, 2001
- 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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Other Clearances by Scien'Tx USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020245 | MODIFICATION TO ISOBAR SPINAL SYSTEM | Feb 1, 2002 | Substantially Equivalent |
| K013447 | ISOBAR SPINAL SYSTEM | Jan 15, 2002 | Substantially Equivalent |
| K013439 | ANTERIOR CERVICAL PLATE SYSTEM | Jan 14, 2002 | Substantially Equivalent |
| K013444 | ISOBAR SPINAL SYSTEM | Nov 16, 2001 | Substantially Equivalent |
| K991326 | ISOBAR SEMI-RIGID SPINAL SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K990721 | ISOLOCK SPINAL SYSTEM | May 27, 1999 | Substantially Equivalent |
| K990118 | ISOBAR SPINAL SYSTEM | Mar 22, 1999 | Substantially Equivalent |