FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXACTECH ALL POLY ACETABULAR CUP
K Number: K934253
·
Decision Apr 29, 1994
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
186
Review Days
241
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Basic Information
- Device Name
- EXACTECH ALL POLY ACETABULAR CUP
- K Number
- K934253
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- August 31, 1993
- Decision Date
- April 29, 1994
- 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.
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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
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MIX EVAC II
FDA 510(k)
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SIMPLEX ENHANCEMENT MIXER
FDA 510(k)
FDA Class 1
·Orthopedic
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