FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K Number: K970697
·
Decision Apr 24, 1997
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
178
Review Days
58
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Basic Information
- Device Name
- OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
- K Number
- K970697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteonics Corp.
- Date Received
- February 25, 1997
- Decision Date
- April 24, 1997
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Osteonics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | Apr 6, 2000 | Substantially Equivalent |
| K980070 | OSTEONICS HA-COATED DEVICES | Jul 23, 1999 | Substantially Equivalent |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | Apr 30, 1999 | Substantially Equivalent |
| 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 |