FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEBER-MAYO WRIST
K Number: K801157
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
303
Review Days
82
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Basic Information
- Device Name
- WEBER-MAYO WRIST
- K Number
- K801157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- May 14, 1980
- Decision Date
- August 4, 1980
- Product Code
- KWM
- 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 |
|---|---|---|---|
| KWM | Prosthesis, Wrist, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWM), ordered by most recent decision date.
VOLZ TOTAL WRIST PROSTHESIS
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·Orthopedic
M.W.P. WRIST PROSTHESIS
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FDA Class 2
·Orthopedic
LAURE WRIST IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
TALEISNIK TOTAL WRIST PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
LODA WRIST PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Depuy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043058 | PINNACLE CONSTRAINED ACETABULAR LINERS | Mar 14, 2005 | Substantially Equivalent |
| K042664 | LPS UPPER EXTREMITY | Dec 8, 2004 | Substantially Equivalent |
| K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY | Jul 22, 2004 | Substantially Equivalent |
| K033959 | LPS | Jul 1, 2004 | Substantially Equivalent |
| K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 | May 28, 2004 | Substantially Equivalent |
| K021478 | DELTA SHOULDER | Nov 18, 2003 | Substantially Equivalent |
| K033329 | DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS | Nov 14, 2003 | Substantially Equivalent |
| 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 |