FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K Number: K945783
·
Decision May 30, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
58
Applicant Total
60
Review Days
186
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Basic Information
- Device Name
- ORTHOMET TITANIUM HYBRID FEMORAL STEM
- K Number
- K945783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthomet, Inc.
- Date Received
- November 25, 1994
- Decision Date
- May 30, 1995
- Product Code
- JDG
- 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 |
|---|---|---|---|
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | FDA class 2 | Orthopedic |
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Other Clearances by Orthomet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT | Jun 7, 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 |
| K932677 | AXIOM TOTAL KNEE SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K931678 | ORTHOMET LHMC FEMORAL STEM | Oct 14, 1994 | Substantially Equivalent |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K923243 | PERFECTA TOTAL HIP SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | Jan 7, 1994 | Substantially Equivalent for Some Indications |