FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHOMIX
K Number: K760636
·
Decision Oct 5, 1976
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
12
Review Days
22
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Basic Information
- Device Name
- ORTHOMIX
- K Number
- K760636
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Diemolding Corp.
- Date Received
- September 13, 1976
- Decision Date
- October 5, 1976
- Product Code
- JDZ
- 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 |
|---|---|---|---|
| JDZ | Mixer, Cement, For Clinical Use | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDZ), ordered by most recent decision date.
EXACTECH ALL POLY ACETABULAR CUP
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PRISM BONE CEMENT MIXING SYSTEM
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STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST
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ZIMMER VACUUM MIXING SYSTEM
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MIX EVAC II
FDA 510(k)
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Other Clearances by Diemolding Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K962749 | THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT | Oct 10, 1996 | Substantially Equivalent |
| K961455 | MEDSHIELD/AEROCHAMBER | Jul 25, 1996 | Substantially Equivalent |
| K902713 | ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS | Jul 25, 1990 | Substantially Equivalent |
| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Jul 18, 1990 | Substantially Equivalent |
| K900754 | RESPIREX 2 | Mar 15, 1990 | Substantially Equivalent |
| K893791 | BREATHING MOUTHPIECE | Jun 23, 1989 | Substantially Equivalent |
| K781759 | RESCAL | Nov 27, 1978 | Substantially Equivalent |
| K780750 | O2 CONNECTOR | Jul 27, 1978 | Substantially Equivalent |
| K770369 | VACON TM | Mar 1, 1977 | Substantially Equivalent |
| K760931 | I.V. DRIP MONITOR ALARM DEVICE, MONIFLO | Jan 5, 1977 | Substantially Equivalent |