FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
K Number: K962152
·
Decision Aug 14, 1996
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
178
Review Days
71
Basic Information
- Device Name
- OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
- K Number
- K962152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- OSTEONICS CORP.
- Date Received
- June 4, 1996
- Decision Date
- August 14, 1996
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titanium Tibial Base Plate
FDA 510(k)
FDA Class 2
·Orthopedic
NextStep Arthropedix Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
EXULT Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
LEGION Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | Dec 16, 1998 | Substantially Equivalent |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | Dec 16, 1998 | Substantially Equivalent |