FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K Number: K083107
·
Decision Feb 9, 2009
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
13
Applicant Total
207
Review Days
112
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Basic Information
- Device Name
- MODIFICATION TO DEPUY NEUFLEX PIP FINGER
- K Number
- K083107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3230
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- October 20, 2008
- Decision Date
- February 9, 2009
- 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 |
Similar 510(k) Clearances
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ASCENSION SILICONE PIP
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