SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k) clearance K020615 · decided 2002-05-13
Clearance details
- K-number
- K020615
- Device name
- SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-25
- Decision date
- 2002-05-13
- Days to decision
- 77 days
- Clearance type
- Special
- 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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| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |