FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SDI TOTAL HIP SYSTEM
K Number: K871299
·
Decision Apr 27, 1987
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
60
Review Days
27
Basic Information
- Device Name
- SDI TOTAL HIP SYSTEM
- K Number
- K871299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- ORTHOMET, INC.
- Date Received
- March 31, 1987
- Decision Date
- April 27, 1987
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
FDA 510(k)
FDA Class 2
·Orthopedic
C-Stem AMT LE Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by ORTHOMET, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT | Jun 7, 1995 | Substantially Equivalent |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | May 30, 1995 | Substantially Equivalent |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Apr 26, 1995 | Substantially Equivalent |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Dec 28, 1994 | Substantially Equivalent |
| K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM | Nov 30, 1994 | Substantially Equivalent for Some Indications |
| K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | Oct 18, 1994 | Substantially Equivalent for Some Indications |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K932677 | AXIOM TOTAL KNEE SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K931678 | ORTHOMET LHMC FEMORAL STEM | Oct 14, 1994 | Substantially Equivalent |
| K923243 | PERFECTA TOTAL HIP SYSTEM | Jan 7, 1994 | Substantially Equivalent |