FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K Number: K112556
·
Decision Sep 28, 2011
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
288
Review Days
26
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Basic Information
- Device Name
- ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
- K Number
- K112556
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics Corp.
- Date Received
- September 2, 2011
- Decision Date
- September 28, 2011
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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