FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DEPUY POROUS COATED GLOBAL SHOULDER
K Number: K943300
·
Decision Oct 31, 1994
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
303
Review Days
115
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Basic Information
- Device Name
- DEPUY POROUS COATED GLOBAL SHOULDER
- K Number
- K943300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Depuy, Inc.
- Date Received
- July 8, 1994
- Decision Date
- October 31, 1994
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| 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 |