FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL INSTRUMENTS, ORTHOPEDIC
K Number: K760325
·
Decision Aug 3, 1976
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
4
Applicant Total
303
Review Days
8
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Basic Information
- Device Name
- SURGICAL INSTRUMENTS, ORTHOPEDIC
- K Number
- K760325
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- July 26, 1976
- Decision Date
- August 3, 1976
- Product Code
- HTX
- 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 |
|---|---|---|---|
| HTX | Rongeur | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTX), ordered by most recent decision date.
MANUAL RONGEUR
FDA 510(k)
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BACK RADIUS CUTTER
FDA 510(k)
FDA Class 1
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FRONT RADIUS CUTTER
FDA 510(k)
FDA Class 1
·Orthopedic
ORTHOPEDIC FORCEPS
FDA 510(k)
FDA Class 1
·Orthopedic
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