FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
K Number: K092122
·
Decision Jul 27, 2009
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
186
Applicant Total
194
Review Days
13
Basic Information
- Device Name
- GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
- K Number
- K092122
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY ORTHOPAEDICS, INC.
- Date Received
- July 14, 2009
- Decision Date
- July 27, 2009
- 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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