FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
K Number: K091956
·
Decision Sep 28, 2010
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
11
Applicant Total
81
Review Days
454
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Basic Information
- Device Name
- HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
- K Number
- K091956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical L.P.
- Date Received
- July 1, 2009
- Decision Date
- September 28, 2010
- Product Code
- OIY
- 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 |
|---|---|---|---|
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | FDA class 2 | Orthopedic |
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