FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRITCHARD SURFACE REPLACEMENT ELBOW
K Number: K810847
·
Decision May 1, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
303
Review Days
35
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Basic Information
- Device Name
- PRITCHARD SURFACE REPLACEMENT ELBOW
- K Number
- K810847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3160
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- March 27, 1981
- Decision Date
- May 1, 1981
- Product Code
- JDB
- 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 |
|---|---|---|---|
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Depuy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Sep 7, 2001 | Substantially Equivalent |