FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOFIX* BIODEGRADABLE FIXATION ROD
K Number: K890902
·
Decision Nov 3, 1989
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
200
Applicant Total
45
Review Days
254
Basic Information
- Device Name
- BIOFIX* BIODEGRADABLE FIXATION ROD
- K Number
- K890902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- DAVIS & GECK, INC.
- Date Received
- February 22, 1989
- Decision Date
- November 3, 1989
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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