FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K Number: K892937
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
279
Review Days
62
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Basic Information
- Device Name
- REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
- K Number
- K892937
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- April 21, 1989
- Decision Date
- June 22, 1989
- 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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MIX EVAC II
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SIMPLEX ENHANCEMENT MIXER
FDA 510(k)
FDA Class 1
·Orthopedic
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