FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
K Number: K040544
·
Decision May 28, 2004
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
303
Review Days
87
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Basic Information
- Device Name
- DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
- K Number
- K040544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy, Inc.
- Date Received
- March 2, 2004
- Decision Date
- May 28, 2004
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K003182 | ORTHOGENESIS LPS SYSTEM | Jun 27, 2001 | Substantially Equivalent |