FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
K Number: K973145
·
Decision Nov 19, 1997
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
41
Review Days
89
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Basic Information
- Device Name
- TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
- K Number
- K973145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sofamor Danek USA,Inc.
- Date Received
- August 22, 1997
- Decision Date
- November 19, 1997
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Sofamor Danek USA,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991031 | COLORADO II SPINAL SYSTEM | May 10, 2000 | Substantially Equivalent |
| K984360 | COLORADO II SPINAL SYSTEM | Mar 30, 2000 | Substantially Equivalent |
| K992928 | CD HORIZON SPINAL SYSTEM | Sep 21, 1999 | Substantially Equivalent |
| K991036 | DANEK PLATE AND SCREW SYSTEM | Sep 14, 1999 | Substantially Equivalent |
| K991198 | DYNA-LOK PLUS SPINAL SYSTEM | Aug 27, 1999 | Substantially Equivalent |
| K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | May 19, 1999 | Substantially Equivalent |
| K981676 | CD HORIZON SPINAL SYSTEM | Jan 28, 1999 | Substantially Equivalent |
| K980184 | CD SPINAL SYSTEM | Dec 18, 1998 | Substantially Equivalent |
| K983672 | DYNA-LOK SPINAL SYSTEM | Dec 16, 1998 | Substantially Equivalent |
| K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | Nov 12, 1998 | Substantially Equivalent |