FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
K Number: K031837
·
Decision Jul 24, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
33
Review Days
38
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
- MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
- K Number
- K031837
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Concepts, Inc.
- Date Received
- June 16, 2003
- Decision Date
- July 24, 2003
- 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 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 |
| K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | Jul 1, 2004 | 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 |
| K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM | Jul 17, 2003 | Substantially Equivalent |