FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOWMEDICA BIPOLAR PROSTHESIS
K Number: K855231
·
Decision Feb 27, 1986
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
373
Review Days
59
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
- HOWMEDICA BIPOLAR PROSTHESIS
- K Number
- K855231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- December 30, 1985
- Decision Date
- February 27, 1986
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWY), ordered by most recent decision date.
b-ONE® Bipolar Head
FDA 510(k)
FDA Class 2
·Orthopedic
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
FDA 510(k)
FDA Class 2
·Orthopedic
CORAIL Cemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SpaceFlex Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
Vario-Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
COPAL exchange G hip spacer
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |