FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
K Number: K090103
·
Decision Feb 11, 2009
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
3
Applicant Total
441
Review Days
27
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Basic Information
- Device Name
- 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- K Number
- K090103
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- January 15, 2009
- Decision Date
- February 11, 2009
- Product Code
- MAY
- 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 |
|---|---|---|---|
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | FDA class 2 | Orthopedic |
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