FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXETER Centralizer, EXETER 2.5mm Plug
K Number: K191414
·
Decision Aug 28, 2019
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
24
Review Days
92
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Basic Information
- Device Name
- EXETER Centralizer, EXETER 2.5mm Plug
- K Number
- K191414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Orthopaedics
- Date Received
- May 28, 2019
- Decision Date
- August 28, 2019
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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