FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
K Number: K033930
·
Decision Jul 28, 2004
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
15
Applicant Total
9
Review Days
223
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Basic Information
- Device Name
- KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
- K Number
- K033930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3810
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kapp Surgical Instrument, Inc.
- Date Received
- December 18, 2003
- Decision Date
- July 28, 2004
- Product Code
- KXE
- 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 |
|---|---|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXE), ordered by most recent decision date.
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FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
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ISOELASTICU
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DISTAL RADIO-ULNAR JOINT IMPLANT
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SBI ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
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|---|---|---|---|
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| K050384 | KAPP BARI-RING, MODEL KS-BR-2005 | Jan 13, 2006 | Substantially Equivalent |
| K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 | Aug 8, 2005 | Substantially Equivalent |
| K050657 | MONDEAL CONTOUR HO SYSTEM | Aug 8, 2005 | Substantially Equivalent |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Aug 29, 2003 | Substantially Equivalent |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | Nov 8, 1984 | Substantially Equivalent |
| K843368 | KAPP SPINAL BUTTON | Sep 12, 1984 | Substantially Equivalent |