FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
MICRO-STRUC. ACETABULAR COMPON- MC2P
K Number: K850352
·
Decision Apr 25, 1985
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
178
Review Days
87
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Basic Information
- Device Name
- MICRO-STRUC. ACETABULAR COMPON- MC2P
- K Number
- K850352
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Osteonics Corp.
- Date Received
- January 28, 1985
- Decision Date
- April 25, 1985
- Product Code
- JDL
- 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 |
|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDL), ordered by most recent decision date.
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|---|---|---|---|
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| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | Mar 25, 1999 | Substantially Equivalent |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Feb 24, 1999 | Substantially Equivalent |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Feb 18, 1999 | Substantially Equivalent |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | Feb 1, 1999 | Substantially Equivalent |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | Dec 18, 1998 | Substantially Equivalent |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | Dec 16, 1998 | Substantially Equivalent |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | Dec 16, 1998 | Substantially Equivalent |