XT3 System
FDA 510(k) clearance K241357 · decided 2025-01-22
Clearance details
- K-number
- K241357
- Device name
- XT3 System
- Applicant
- Biodynamik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-14
- Decision date
- 2025-01-22
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- JDW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (K260073) | Biodynamik, Inc. | 2026-02-10 |
| Meduloc Intramedullary Fracture Fixation (IFF) System (K250316) | Meduloc, LLC | 2025-10-29 |
| MAVERICK Mini External Fixation System (K223112) | Smith & Nephew, Inc. | 2022-12-08 |
| MAVERICK External Fixation System (K213874) | Smith & Nephew, Inc. | 2022-02-11 |
| Steinmann Pins and Kirschner Wires (K211508) | Stryker GmbH | 2021-10-05 |
| Extended HA Half Pins (K210784) | Smith & Nephew, Inc. | 2021-04-02 |
| Syntec Non-Sterile Steinmann Pins System (K200933) | Syntec Scientific Corporation | 2020-05-05 |
| Orthopedic Fixation Pin (K191803) | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| Temporary Fixation Pins (K192768) | Eisertech, LLC | 2019-12-26 |
| SMV Scientific K-Wire and Pins (K182171) | Summit Medventures | 2018-10-25 |
| Ultima HA Coated Half Pins and Wire (K163487) | Vilex IN Tennessee, Inc. | 2017-02-13 |
| ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite (K150661) | Citieffe S.R.L. | 2015-07-07 |
Recalls involving this device
No recalls on record reference this clearance.