FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONE CEMENT APPLICATOR
K Number: K780266
·
Decision Feb 28, 1978
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
10
Applicant Total
376
Review Days
11
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Basic Information
- Device Name
- BONE CEMENT APPLICATOR
- K Number
- K780266
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4200
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Zimmer, Inc.
- Date Received
- February 17, 1978
- Decision Date
- February 28, 1978
- Product Code
- KIH
- 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 |
|---|---|---|---|
| KIH | Dispenser, Cement | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
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BRIGHAM TIBIAL CEMENT PRESSURIZER
FDA 510(k)
FDA Class 1
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