OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
FDA 510(k) clearance K983382 · decided 1998-12-11
Clearance details
- K-number
- K983382
- Device name
- OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-25
- Decision date
- 1998-12-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cement recall (Z-1043-2015) | Stryker Howmedica Osteonics Corp. | 2015-02-03 |
| Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip recall (Z-0072-2008) | Stryker Howmedica Osteonics Corp. | 2007-10-25 |
| HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prost recall (Z-0073-2008) | Stryker Howmedica Osteonics Corp. | 2007-10-25 |
| Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howm recall (Z-1261-2007) | Stryker Howmedica Osteonics Corp. | 2007-09-26 |