FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K Number: K970544
·
Decision Sep 12, 1997
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
13
Applicant Total
303
Review Days
212
Basic Information
- Device Name
- DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
- K Number
- K970544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3230
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy, Inc.
- Date Received
- February 12, 1997
- Decision Date
- September 12, 1997
- Product Code
- KYJ
- 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 |
|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K021478 | DELTA SHOULDER | Nov 18, 2003 | Substantially Equivalent |
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| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | Sep 26, 2003 | Substantially Equivalent |
| 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 |