FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K Number: K033816
·
Decision Mar 2, 2004
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
402
Review Days
84
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
- SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
- K Number
- K033816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- December 9, 2003
- Decision Date
- March 2, 2004
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDQ), ordered by most recent decision date.
Stitch Cerclage Suture Tapes
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
FDA 510(k)
FDA Class 2
·Orthopedic
Mbrace Cable
FDA 510(k)
FDA Class 2
·Orthopedic
ACCORD Cable System
FDA 510(k)
FDA Class 2
·Orthopedic
VariTrax Sternal CircumFixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Radiopaque FiberTape Cerclage sutures
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Synthes (Usa)
| K Number | Device Name | ||
|---|---|---|---|
| K131984 | SYNTHES SYNSONIC ULNA NAIL | Mar 31, 2014 | Substantially Equivalent |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Dec 5, 2011 | Substantially Equivalent |
| K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | Aug 8, 2011 | Substantially Equivalent |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Jul 28, 2011 | Substantially Equivalent |
| K103002 | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM | Mar 2, 2011 | Substantially Equivalent |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Jan 21, 2011 | Substantially Equivalent |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Dec 16, 2010 | Substantially Equivalent |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES | Dec 9, 2010 | Substantially Equivalent |
| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 3, 2010 | Substantially Equivalent |