FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) TITANIUM WIRE
K Number: K041333
·
Decision Aug 27, 2004
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
31
Applicant Total
402
Review Days
100
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) TITANIUM WIRE
- K Number
- K041333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- May 19, 2004
- Decision Date
- August 27, 2004
- Product Code
- GAQ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAQ), ordered by most recent decision date.
CoNextions TR Tendon Repair System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Wego-Stainless Steel
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MERISTEEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgical Stainless Steel Suture, Stainless Steel Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |