FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSY SHOULDER PLATE IMPLANT
K Number: K040850
·
Decision Jun 24, 2004
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
11
Review Days
85
Basic Information
- Device Name
- TSY SHOULDER PLATE IMPLANT
- K Number
- K040850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORTHOPEDIC SCIENCES, INC
- Date Received
- March 31, 2004
- Decision Date
- June 24, 2004
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
FDA 510(k)
FDA Class 2
·Orthopedic
Genostis Osteosynthesis System
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Scapula Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
FDA 510(k)
FDA Class 2
·Orthopedic
LORRAINE 2.5/3.5mm Distal Humerus System
FDA 510(k)
FDA Class 2
·Orthopedic
Montblanc Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by ORTHOPEDIC SCIENCES, INC
| K Number | Device Name | ||
|---|---|---|---|
| K133018 | OSI Q SYSTEM ARTHROSCOPES | Feb 26, 2014 | Substantially Equivalent |
| K091398 | ARTHROSCOPE | Aug 26, 2009 | Substantially Equivalent |
| K072175 | TITANIUM HIP TOOL LOCKING PLATE | Aug 21, 2007 | Substantially Equivalent |
| K063709 | TS-BONE HIP TOOL | Jan 4, 2007 | Substantially Equivalent |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | Nov 1, 2006 | Substantially Equivalent |
| K052538 | S-BONE HIP TOOL | Oct 7, 2005 | Substantially Equivalent |
| K051032 | TITANIUM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K051181 | CUSTOM-HIP TOOL | May 23, 2005 | Substantially Equivalent |
| K040493 | OUTOLOGOUS SPINAL FIXATION SYSTEM | Sep 3, 2004 | Substantially Equivalent |
| K022139 | HIP TOOL IMPLANT | Sep 23, 2002 | Substantially Equivalent |