FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OMC ORTHOMET CANNULATED SCREW
K Number: K862157
·
Decision Aug 29, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
60
Review Days
85
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Basic Information
- Device Name
- OMC ORTHOMET CANNULATED SCREW
- K Number
- K862157
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Orthomet, Inc.
- Date Received
- June 5, 1986
- Decision Date
- August 29, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
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 |
| 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 |