FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOFFMANN II CARBON CONNECTING ROD
K Number: K961916
·
Decision Aug 1, 1996
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
36
Review Days
76
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Basic Information
- Device Name
- HOFFMANN II CARBON CONNECTING ROD
- K Number
- K961916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica, Inc.
- Date Received
- May 17, 1996
- Decision Date
- August 1, 1996
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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