FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIX EVAC BONE CEMENT
K Number: K760617
·
Decision Oct 5, 1976
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
12
Applicant Total
124
Review Days
22
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Basic Information
- Device Name
- MIX EVAC BONE CEMENT
- K Number
- K760617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4210
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stryker 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
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