FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
NON CONSTRAINED TOTAL SHOULDER SYSTEM
K Number: K895802
·
Decision Dec 27, 1989
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- NON CONSTRAINED TOTAL SHOULDER SYSTEM
- K Number
- K895802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Orthopaedic Medical Group, Inc.
- Date Received
- September 28, 1989
- Decision Date
- December 27, 1989
- 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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