FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARNE M.T.P.J. ORTHOPEDIC IMPLANT
K Number: K781380
·
Decision Feb 21, 1979
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
13
Applicant Total
1
Review Days
194
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Basic Information
- Device Name
- MARNE M.T.P.J. ORTHOPEDIC IMPLANT
- K Number
- K781380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3230
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Farah , Ltd.
- Date Received
- August 11, 1978
- Decision Date
- February 21, 1979
- Product Code
- KYJ
- 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 |
|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | FDA class 2 | Orthopedic |
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