FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CEMENTRIFUGE
K Number: K851205
·
Decision Jul 16, 1985
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
30
Review Days
112
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Basic Information
- Device Name
- CEMENTRIFUGE
- K Number
- K851205
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- March 26, 1985
- Decision Date
- July 16, 1985
- 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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REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
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ZIMMER VACUUM MIXING SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
MIX EVAC II
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Biodynamic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | Mar 31, 1999 | Substantially Equivalent |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Mar 17, 1999 | Substantially Equivalent |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Mar 17, 1999 | Substantially Equivalent |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Jun 1, 1998 | Substantially Equivalent |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | Apr 3, 1998 | Substantially Equivalent |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Mar 12, 1998 | Substantially Equivalent for Some Indications |
| K972403 | BTI CORTICAL BONE SCREWS | Aug 29, 1997 | Substantially Equivalent |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Nov 13, 1996 | Substantially Equivalent |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Nov 4, 1996 | Substantially Equivalent |