FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RABEA CEMENT RESTRICTOR
K Number: K020836
·
Decision Jun 11, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
6
Review Days
89
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RABEA CEMENT RESTRICTOR
- K Number
- K020836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Signus Medical, LLC
- Date Received
- March 14, 2002
- Decision Date
- June 11, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDK), ordered by most recent decision date.
Mectaplug PE II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMI CEMENT RESTRICTOR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFE SPINE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINAL USA CEMENT RESTRICTOR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERBODY INNOVATIONS CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Signus Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K081108 | MONOPOLY PEDICLE SCREW SYSTEM | Jul 14, 2008 | Substantially Equivalent |
| K052096 | NUBIC SPINAL IMPLANT | Aug 16, 2005 | Substantially Equivalent |
| K031455 | CONKLUSION PEDICLE SCREW SYSTEM | Oct 22, 2003 | Substantially Equivalent |
| K031757 | PEEK TETRIS SPINAL IMPLANT | Jul 30, 2003 | Substantially Equivalent |
| K022793 | TETRIS SPINAL IMPLANT | Apr 8, 2003 | Substantially Equivalent |