510(k) K260073
- Device
- XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm
- Applicant
- Biodynamik, Inc.
- 510(k) number
- K260073
- Product code
- JDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-10
- Date received
- 2026-01-09
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Threaded
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Johnny Chen
- Address
- 11 Orchard Suite 107 Lake Forest CA US 92630 92630
FDA Registration Numbers#
- 2029275
- 3014129047
- 3014315669
- 2183449
- 2919128
- 3010041499
- 2244478
- 1423662
- 3021008900
- 3006513362
- 2431166
- 3005809810
- 3019356409
- 3033509898
- 2648623
- 3008110533
- 3005562917
- 3007993775
- 2936485
- 3002907620
- 3003108161
- 1421101
- 3009973505
- 3010331645
- 3015895045
- 1043653
- 3017406274
- 3008868758
- 3014315560
- 3006395932
- 2245304
- 1424434
- 3011656326
- 3014522470
- 3003249380
- 1018470
- 3011301313
- 3010470577
- 3009756327
- 3008951116
- 9611863
- 3007887127
- 1219930
- 8043792
- 1057425
- 1526439
- 1818910
- 3006460162
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3015231789
- 3008812560
- 3006783837
- 9611274
- 3025141
- 3005180920
- 1226074
- 2025102
- 3000270450
- 8010468
- 1060840
- 3009417901
- 3015440604
- 1020279
- 3004983210
- 3015709929
- 1720747
- 3033536312
- 1825034
- 3003639920
- 2183946
- 1226544
- 3030966822
- 1221934
- 3011277306
- 1833986
- 3009513193
Source Documents#
Other 510(k) Records For Product Code JDW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | 2025-10-29 |
| K241357 | XT3 System | Biodynamik, Inc. | 2025-01-22 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021-10-05 |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021-04-02 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020-05-05 |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018-10-25 |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017-02-13 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES | Vilex, Inc. | 2014-07-23 |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | 2014-05-30 |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | 2013-10-17 |