FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL TOTAL SHOULDER
K Number: K914695
·
Decision Jan 16, 1992
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
303
Review Days
90
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Basic Information
- Device Name
- GLOBAL TOTAL SHOULDER
- K Number
- K914695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Depuy, Inc.
- Date Received
- October 18, 1991
- Decision Date
- January 16, 1992
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| 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 |