FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MECRON CANCELLOUS CANNULATED BONE SCREWS
K Number: K810205
·
Decision Feb 9, 1981
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- MECRON CANCELLOUS CANNULATED BONE SCREWS
- K Number
- K810205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Serrano Intl.
- Date Received
- January 26, 1981
- Decision Date
- February 9, 1981
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Serrano Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K851409 | UNILOC TOTAL HIP PROSTHESIS | Nov 22, 1985 | Substantially Equivalent |
| K820619 | MECRON(R) ACETABULAR NETS TM | May 14, 1982 | Substantially Equivalent |
| K820899 | MECRON VOORHOEVE TITANIUM SHEATH | May 14, 1982 | Substantially Equivalent |
| K820852 | MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY | Apr 15, 1982 | Substantially Equivalent |
| K810497 | BONE FIXACTION SCREW | Mar 11, 1981 | Substantially Equivalent |