Product code KTT
- Device name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | 2024-09-18 |
| K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024-05-30 |
| K240049 | LINK(TM) External Fixator | Metric Medical Devices, Inc. | 2024-05-29 |
| K233741 | Hoffmann LRF System | Stryker GmbH | 2023-12-21 |
| K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023-11-30 |
| K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023-10-18 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023-10-12 |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023-07-26 |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | 2023-06-16 |
| K223786 | Orthex External Fixation System | OrthoPediatrics Corp. | 2023-02-10 |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022-08-25 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | 2022-06-06 |
| K220809 | Drive Rail System | OrthoPediatrics Corp. | 2022-04-08 |
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021-11-08 |
| K212044 | TrueLok Evo | Orthofix Srl | 2021-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327079623 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079609 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079586 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079524 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079241 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079272 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079333 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079395 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079401 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079449 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079470 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079500 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327079517 | HOFFMANN | Stryker GmbH | 2018-09-24 |
| 07613327072402 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327072693 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327072686 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613327072426 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 07613154164134 | HOFFMANN | Stryker GmbH | 2016-09-24 |
| 08032909623600 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623624 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623730 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623747 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623792 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909623952 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624140 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624157 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624164 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624171 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624188 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |
| 08032909624195 | ST.A.R. 90 F4 | CITIEFFE SRL | 2015-10-21 |