FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEO 9MM IC TIBIAL NAIL
K Number: K984353
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
178
Review Days
9
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OSTEO 9MM IC TIBIAL NAIL
- K Number
- K984353
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteonics Corp.
- Date Received
- December 7, 1998
- Decision Date
- December 16, 1998
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
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 |
| K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM | Dec 11, 1998 | Substantially Equivalent |