FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K Number: K012255
·
Decision Aug 1, 2001
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
99
Review Days
14
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Basic Information
- Device Name
- MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
- K Number
- K012255
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date Received
- July 18, 2001
- Decision Date
- August 1, 2001
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medtronic Sofamor Danek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251193 | Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft | Jun 12, 2025 | Substantially Equivalent |
| K243706 | Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules | Jan 17, 2025 | Substantially Equivalent |
| K230716 | Robotic Graft Delivery Instruments | Jul 18, 2023 | Substantially Equivalent |
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Sep 5, 2014 | Substantially Equivalent |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | Jul 9, 2014 | Substantially Equivalent |
| K140449 | CD HORIZON SPINAL SYSTEM | Mar 25, 2014 | Substantially Equivalent |
| K132897 | CLYDESDALE SPINAL SYSTEM | Dec 11, 2013 | Substantially Equivalent |
| K133216 | CRESCENT SPINAL SYSTEM | Nov 22, 2013 | Substantially Equivalent |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Sep 26, 2013 | Substantially Equivalent |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | Sep 23, 2013 | Substantially Equivalent |