FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K Number: K011985
·
Decision Nov 2, 2001
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
529
Review Days
129
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Basic Information
- Device Name
- SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
- K Number
- K011985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- June 26, 2001
- Decision Date
- November 2, 2001
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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