FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K Number: K040096
·
Decision Jul 1, 2004
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
33
Review Days
163
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Basic Information
- Device Name
- SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
- K Number
- K040096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Concepts, Inc.
- Date Received
- January 20, 2004
- Decision Date
- July 1, 2004
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Spinal Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | May 19, 2005 | Substantially Equivalent |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | Apr 15, 2005 | Substantially Equivalent |
| K033663 | SPINAL CONCEPTS INC. CODA | May 27, 2004 | Substantially Equivalent |
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS | Feb 18, 2004 | Substantially Equivalent |
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM | Sep 17, 2003 | Substantially Equivalent |
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM | Sep 11, 2003 | Substantially Equivalent |
| K031318 | TRAXIS CEMENT RESTRICTOR | Aug 22, 2003 | Unknown |
| K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM | Aug 7, 2003 | Substantially Equivalent |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | Jul 24, 2003 | Substantially Equivalent |
| K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM | Jul 17, 2003 | Substantially Equivalent |