ABG III MONOLITHIC HIP STEM
FDA 510(k) clearance K123604 · decided 2013-08-16
Clearance details
- K-number
- K123604
- Device name
- ABG III MONOLITHIC HIP STEM
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-21
- Decision date
- 2013-08-16
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- MAY
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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| ABG II MONOLITHIC HIP STEM (K110807) | Stryker Corp. | 2011-05-25 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary sta recall (Z-0875-2016) | Stryker Howmedica Osteonics Corp. | 2016-02-25 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| 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 |