FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOENIX BONE SCREWS PBS-TYPE SERIES
K Number: K930125
·
Decision Dec 30, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
10
Applicant Total
3
Review Days
352
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Basic Information
- Device Name
- PHOENIX BONE SCREWS PBS-TYPE SERIES
- K Number
- K930125
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3025
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Phoenix Bioengineering, Inc.
- Date Received
- January 12, 1993
- Decision Date
- December 30, 1993
- Product Code
- HXA
- 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 |
|---|---|---|---|
| HXA | Prosthesis, Tendon, Passive | FDA class 2 | Orthopedic |
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