Emerge External Fixation System
FDA 510(k) K140675 · Emerge Medical, Inc.
510(k) numberK140675
Submission
- Device name
- Emerge External Fixation System
- Applicant
- Emerge Medical, Inc.
Denver, CO, US - Received
- March 18, 2014
- Decision date
- June 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141347 | Emerge Medical Im Nail SystemHSB · Traditional | 10/02/2014SE |
| K140107 | Emerge Medical Distal Radius SetHRS · Traditional | 03/13/2014SE |
| K140119 | Emerge Medical Periarticular and Locking Large Fragment SystemHRS · Traditional | 03/12/2014SE |
| K140098 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 03/12/2014SE |
| K133536 | Emerge Medical Bone Plate SystemHRS · Traditional | 02/26/2014SE |
| K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate SystemHRS · Traditional | 01/28/2014SE |
| K133452 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 01/08/2014SE |
| K131480 | Emerge Medical Locking One-Third Tubular Plate SystemHRS · Traditional | 07/03/2013SE |
| K122489 | Emerge Medical Solid Bone ScrewsHWC · Traditional | 12/10/2012SE |
| K102343 | Emerge Medical Cannulated Screw Fixation SystemHWC · Traditional | 11/23/2010SE |
Questions and answers
When was Emerge External Fixation System cleared by the FDA?
Emerge External Fixation System (K140675) received a 510(k) decision of Substantially Equivalent on June 10, 2014, 84 days after the submission was received.
What is the product code of K140675?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.