TITAN TIBIAL NAIL
FDA 510(k) clearance K003018 · decided 2000-12-15
Clearance details
- K-number
- K003018
- Device name
- TITAN TIBIAL NAIL
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-27
- Decision date
- 2000-12-15
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- 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 |
|---|---|---|
| Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: St recall (Z-2374-2020) | Stryker GmbH | 2020-06-16 |
| Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implant recall (Z-2375-2020) | Stryker GmbH | 2020-06-16 |
| Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm Catalog Number: 18964032S - Produ recall (Z-2380-2020) | Stryker GmbH | 2020-06-16 |
| Stryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S - Produ recall (Z-2383-2020) | Stryker GmbH | 2020-06-16 |
| Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, recall (Z-0214-2008) | Stryker Howmedica Osteonics Corp. | 2007-11-16 |
| T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S. recall (Z-1295-03) | Stryker Howmedica Osteonics | 2003-10-15 |
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 |