FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAL HEAD IMPLANT
K Number: K011819
·
Decision Jun 19, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
32
Applicant Total
18
Review Days
8
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Basic Information
- Device Name
- RADIAL HEAD IMPLANT
- K Number
- K011819
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3170
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avanta Orthopaedics, Inc.
- Date Received
- June 11, 2001
- Decision Date
- June 19, 2001
- Product Code
- KWI
- 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 |
|---|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWI), ordered by most recent decision date.
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Revolution Radial Head
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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 |
| 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 |
| K982268 | ULNAR HEAD IMPLANT | Dec 4, 1998 | Substantially Equivalent |