FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K Number: K003131
·
Decision Nov 2, 2000
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
441
Review Days
27
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Basic Information
- Device Name
- MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
- K Number
- K003131
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- October 6, 2000
- Decision Date
- November 2, 2000
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
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