FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K Number: K944836
·
Decision Apr 10, 1995
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
178
Review Days
192
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
- OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
- K Number
- K944836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Osteonics Corp.
- Date Received
- September 30, 1994
- Decision Date
- April 10, 1995
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEH), ordered by most recent decision date.
Allure Hip Stem and Intramedullary Plugs
FDA 510(k)
FDA Class 2
·Orthopedic
Mfinity Femoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Trivicta® Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Resolve Modular Revision Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Alteon® HA Femoral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
World Liner
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 |
| 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 |