FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
K Number: K844415
·
Decision Jan 23, 1985
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
36
Applicant Total
303
Review Days
70
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Basic Information
- Device Name
- POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
- K Number
- K844415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- November 14, 1984
- Decision Date
- January 23, 1985
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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