FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ARTHREX STAPLES
K Number: K943492
·
Decision Feb 1, 1995
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
348
Review Days
197
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Basic Information
- Device Name
- ARTHREX STAPLES
- K Number
- K943492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Arthrex, Inc.
- Date Received
- July 19, 1994
- Decision Date
- February 1, 1995
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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