FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K Number: K965204
·
Decision Jun 3, 1997
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
18
Review Days
159
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Basic Information
- Device Name
- AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
- K Number
- K965204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Avanta Orthopaedics, Inc.
- Date Received
- December 26, 1996
- Decision Date
- June 3, 1997
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
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Other Clearances by Avanta Orthopaedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K021859 | WRIST IMPLANT | Dec 2, 2002 | Substantially Equivalent |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Nov 27, 2002 | Substantially Equivalent |
| K013629 | FINGER JOINT PROSTHESIS | Jan 25, 2002 | Substantially Equivalent |
| K010847 | K'FIX | Jun 19, 2001 | Substantially Equivalent |
| K011819 | RADIAL HEAD IMPLANT | Jun 19, 2001 | Substantially Equivalent |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | May 30, 2001 | Substantially Equivalent |
| K010786 | ULNAR HEAD IMPLANT | Apr 11, 2001 | Substantially Equivalent |
| K002644 | RADIAL HEAD IMPLANT | Nov 20, 2000 | Substantially Equivalent |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | Apr 29, 1999 | Substantially Equivalent |