FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
K Number: K103124
·
Decision Nov 19, 2010
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
81
Review Days
28
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Basic Information
- Device Name
- SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
- K Number
- K103124
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- October 22, 2010
- Decision Date
- November 19, 2010
- 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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