FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ANATOMIC TOE SYSTEM
K Number: K911552
·
Decision Jun 28, 1991
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
10
Applicant Total
3
Review Days
81
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Basic Information
- Device Name
- ANATOMIC TOE SYSTEM
- K Number
- K911552
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Orthopaedic Biosystems
- Date Received
- April 8, 1991
- Decision Date
- June 28, 1991
- Product Code
- LZJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | FDA unclassified | Unknown |
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