FDA 510(k)
Substantially Equivalent
🇺🇸 United States
THE ICR KNEE
K Number: K820719
·
Decision May 12, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- THE ICR KNEE
- K Number
- K820719
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Ortomed Corp.
- Date Received
- March 16, 1982
- Decision Date
- May 12, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by American Ortomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K842518 | UNILOC-CEMENTLESS & SELF TAP ACETABULAR | Jan 30, 1985 | Substantially Equivalent |
| K842466 | TITANIUM MITTELMEIER TYPE ACETABULAR | Jan 30, 1985 | Substantially Equivalent |
| K842465 | UNILOC | Nov 19, 1984 | Substantially Equivalent |
| K840413 | CEMENT RESTRICTOR | Mar 5, 1984 | Substantially Equivalent |
| K780497 | SPHERISTEM TOTAL HIP PROSTHESIS | Jun 14, 1978 | Substantially Equivalent |