FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORTICAL BONE SCREW
K Number: K915448
·
Decision Feb 28, 1992
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
74
Review Days
81
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Basic Information
- Device Name
- CORTICAL BONE SCREW
- K Number
- K915448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dow Corning Wright
- Date Received
- December 9, 1991
- Decision Date
- February 28, 1992
- 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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| K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE | Nov 30, 1993 | Substantially Equivalent |
| K925900 | LACEY REVISION FEMORAL COMPONENT | Aug 24, 1993 | Substantially Equivalent |
| K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP | Aug 6, 1993 | Substantially Equivalent for Some Indications |
| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 2, 1993 | Substantially Equivalent |